tag:blogger.com,1999:blog-72322289411294316802024-03-06T12:02:40.396-08:00Antiphospholipid Antibody Syndrome (APS) - SAY NO to Home INR and Finger Stick Machines!!I started this blog to help get the word out that Home INR and finger stick machines may NOT be safe to use for patients with Antiphospholipid Antibody Syndrome. If you have APS, please read! Thanks!Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.comBlogger25125tag:blogger.com,1999:blog-7232228941129431680.post-30756408060089500212010-02-04T19:09:00.001-08:002010-02-04T19:13:11.161-08:00Inaccuracies Even WITHOUT Having APS<p>Source: <a title="http://www.dailystrength.org/c/Deep_Vein_Thrombosis_DVT/forum/8947591-digital-inr-meters" href="http://www.dailystrength.org/c/Deep_Vein_Thrombosis_DVT/forum/8947591-digital-inr-meters">http://www.dailystrength.org/c/Deep_Vein_Thrombosis_DVT/forum/8947591-digital-inr-meters</a></p> <p>Notice, this is NOT an APS forum, group, what have you. This is something that showed up in my Google alerts recently. </p> <p>These people DO NOT claim to have APS (who knows though if they’ve been tested for it)…and check out the original source. This is from 2010. </p> <p>Scary stuff…</p> <blockquote> <p>Just a quick heads up for those that don't do a blood draw to check your INR. I went in last Thursday and had mine tested on the digital meter and I came back at a 5.4. I asked the lady when was the last time they used a test strip on it and she said that she didn't know. I asked if we could try it on another one. After doing it on the second machine I was at 2.7. That is a big difference. She was going to have me not take my next to doses before we did the recheck. Thank god we did because I would have been really low. I was a 4.4 and 4.8 on the test the two previous weeks so I am pretty sure the machine had been bad for awhile. Moral of the story is, if you test really high asked to be rechecked on a different machine.</p> </blockquote> <p>Two back to back readings. Both different. And to me, the moral would be…don’t get tested on the machines. Period. </p> <p>Same person posting…a couple days later:</p> <blockquote> <p>…it's an Inratio, but didn't see anything saying it was a 2. I had my blood checked today and was at 4.1 then tested on another one and I was 1.2. I had them do a blood draw so I guess i will find out soon what it really is. I hope It's not at 1.2 though. I think I am done with those meters at this place. Two weeks in a row and the shit is all messed up. Be careful to all of you who use them meters....</p> </blockquote> <p>Again…two different readings, two different machines and almost a 3 point difference! That’s HUGE!</p> <p>The person posted back the results from his vein draw…wait for it…wait for it:</p> <blockquote> <p>Just got word on the blood draw and I was 3.3.. Neither one of the meters were close. They are making it sound like I am the only one this has happened to.. They seem to think it's something with my blood and want me to draws from now on. He said make an appointment for next Wed. and to come back in for the results on Fri. I told him to fly a kite and that he could just tell me over the phone. He replied " I guess we could do that, but would like to know how you are feeling and if you are having pain in your legs." I then said I could tell him when they call with the results.. What a smart one!!</p> </blockquote> <p>I love how the clinic thinks it’s something wrong with this poster’s blood. Like the machines can’t possibly be inaccurate or anything. </p> <p>Hmm… let’s review. 1.2 on one machine. 4.1 on another machine. 3.3 from the vein draw. Yet people put their trust and their lives in the hands of these machines? </p> <p>Wow. Just wow.</p> <p>I will be keeping my eye on this site/thread because it’s new and still going on. </p> <p>Just food for thought.  </p> <p>Source: <a href="http://www.dailystrength.org/c/Deep_Vein_Thrombosis_DVT/forum/8947591-digital-inr-meters">http://www.dailystrength.org/c/Deep_Vein_Thrombosis_DVT/forum/8947591-digital-inr-meters</a></p> Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com2tag:blogger.com,1999:blog-7232228941129431680.post-34198723888800057442010-02-03T20:02:00.001-08:002010-02-03T20:02:42.448-08:0069 Profile Views and over 160 Page Loads in the Past 2 days!<p>Ooh, I guess I pissed someone off!</p> <p>Funny that this blog has been here since 2007. Look at the archives. 2007 was the first post. </p> <p> </p> <p>Glad I got the blog all pretty before I got all this traffic! Let me say welcome to all of the new followers or readers. </p> <p><em>I really appreciate all of your clicks. The more you visit my site, the higher it will get in the search engines and the more people I will be able educate!! So, you may not realize it, but you’re helping my cause.</em> <em>Thank you!</em></p> <p> </p> <p>I got a few comments I’d like to respond to. </p> <p> </p> <p>One person asked to have their name removed. Since they didn’t leave their name, I don’t know <strong>WHICH</strong> name to removed. So I went through recent posts and removed one name. I tried to removed the names from the most recent posts and will remove all names in the future. </p> <p>The 2nd comment was something about netiquette and a specific APS group. This comment I deleted. Let me say here that I am not affiliated with ANY of the APS groups, foundations, forums, however, I am a MEMBER of many of them. I am only here to educate. I have Google alerts that send me information on APS and INR machines. I also utilize Google reader. Two excellent tools. </p> <p>So you may ask yourself why a lot of my links are from the APSFA site then? Well, when I was initially researching, that was where I found my information because their site and links are pretty high in the search engines.</p> <p> </p> <p>And if you look at the entire blog, not just the last 5 or so posts, you’ll see that my testimonies come from all different sources: forums, youtube, facebook, and even yahoo groups. So, they are not group specific. I post em as I see em…wherever I see em. </p> <p> </p> <p>Comments are now being moderated as well. For now, I will continue to accept anonymous comments, but if the nasty and accusing comments continue, then I change that as well. I don’t want to. </p> <p>And since so many people are reading today, I posted a few more things for you to ponder, or scoff at…and then some links that may open your eyes. As well as my own story which I have not shared…and the reason why I made this blog in the first place. </p> <p> </p> <p>I also have a challenge for those who SWEAR by these machines. </p> <p>Show me PROOF that they are accurate. </p> <p>Give me the black and white. </p> <p>Bet you can’t. </p> <p>Leave it in a comment. </p> <p> </p> <p>I dare you to.</p> Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com2tag:blogger.com,1999:blog-7232228941129431680.post-7224985606784749982010-02-03T20:00:00.001-08:002010-02-03T20:05:45.238-08:00My Mother's INR Machine Story<p>I’d like to share my own APS story with you.</p> <p>My mother had APS. </p> <p>We found out after she had a DVT and actually, she did have multiple miscarriages…but we just chocked that up to “God’s will” – she had the babies she was meant to have – that sort of thing. Not everyone believes, so I don’t want to dwell on that. And she always had migraines too and horrible vertigo at times.</p> <p>She was put on Coumadin after the DVT and her doctor set her up to get her INR drawn at an anticoagulation clinic. She got her INR drawn there using a finger stick machine and we didn’t think anything of it. It was a quick trip to the clinic every week and that was all. We never had any reason to question the results. </p> <p>The nurses at the clinic mentioned that she could get the same machine they used there to test her INR at home and the hospital social worker helped her get the approval through Medicare. It would be so much more convenient for her to test at home and since it was safe enough to use at the hospital, then it would be safe enough to use at home!</p> <p>Right…? </p> <p>WRONG!!</p> <p>She had been using the machine for a little over a year to test her INR. Her range was 2.5-3.5 and she usually was within range. We never did comparison draws, we didn’t know we needed to or should have because the hospital never did and it was the same machine as the hospital used. </p> <p>At the end of August she had said that her calf was achy. We didn’t see anything and since her INR was in range, we didn’t worry about it too much. She had a doctor’s appointment coming up and we decided it could wait until then. </p> <p>A couple days later, she complained of having shortness of breath and chest pains. We immediately checked her INR and it was 3.1, which was in her range. We decided to take her to the emergency room though because we weren’t sure what was going on. </p> <p>They took her right back, did an EKG, drew some blood and hooked her up to a heart monitor. The doctor came and said there were some abnormalities on her EKG and that they wanted to do a chest x-ray but didn’t seem too concerned, just said it was a “precaution”. </p> <p>As we waited she was complaining that it was getting harder to breath and that her chest was really hurting. I was going to get her nurse but her monitor started making all this noise and then it was like all the emergency room doctor shows you see on tv where people are all rushing to the curtained room with carts and my dad and I were shoved out of the room wondering what the hell was going on. </p> <p>It was probably only minutes, but seemed like time stood still. </p> <p>The doctor who saw my mother earlier said that they lost her and that he was sorry, but they did everything they could. </p> <p>My mother died from a Pulmonary Embolism from a DVT in her calf on September 2, 2007. She was 58 years old. </p> <p>When we got her medical records after her death her INR from the blood draw in the hospital was a 0.9. </p> <p>It was a 3.1 from her trusted machine just earlier that afternoon. </p> <p>The strips were new and properly stored, the machine was clean, and the INR finger stick machine reading was WRONG. </p> <p>And my mother died. </p> <p>Had I known THEN what I know NOW my mother NEVER EVER would have even gotten finger stick draws at the clinic!! But we never KNEW better. We were told the machine was so convenient and it was the exact same brand as the hospital used. THE SAME MACHINE. </p> <p>And it was still WRONG. And my mother died. </p> <p> </p> <p>So now you know why this is important to me and why I am educating people. </p> <p> </p> <p>Convenience is not worth a life. The machines are wrong for APS patients. Plain and simple. </p> <p>Even the documents that I have found from the machine manufacturers say they are aren’t accurate for APS patients…and the more I read, the more angry I get about it. If it was your loved one or mother, wouldn’t you feel the same way?</p> <p>My mother didn’t have to die. </p> <p> </p> <p>If I prevent ONE person from using these machines, then my work here has been worth it. I can’t get my mom back, but I can make sure that people are AWARE of the inaccuracies. No matter what doctor or group or patient says how wonderful the machine is…is convenience worth a LIFE? </p> <p> </p> <p>Possibly YOUR life? Think about it. </p>Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com1tag:blogger.com,1999:blog-7232228941129431680.post-47974998723740828412010-02-03T19:05:00.001-08:002010-02-03T19:05:41.943-08:00Need More Proof?<p>Links to back up the claims. Proof in black and white. What more do you need?</p> <p>Happy reading. <img alt="Disappointed" src="http://messenger.msn.com/MMM2006-04-19_17.00/Resource/emoticons/what_smile.gif" /></p> <p> </p> <p><a href="http://www.apsfa.org/docs/APSFAVol5Spring2007.pdf" target="_blank"><font color="#0066cc">*INR Monitoring in Patients with Antiphospholipid Antibodies with Finger Stick INR Machines.</font></a> <br />by: Stephan Moll, MD. A superb way to monitor INRs (International Normalized Ratio) in patients on oral anticoagulants who do NOT have antiphospholipid antibodies (APLA) is though use of “point of care instruments”, where the INR is tested on blood from a finger stick. This method gives fast results and is used by many physicians’ offices and by some patients at home. However, in patients with APLA on oral anticoagulants these instruments may give inaccurate readings.   <br /> <br /><a href="http://apsno2homeinr.blogspot.com/" target="_blank"><font color="#0066cc">Antiphospholipid Antibody Syndrome (APS) - NO to Home INR Machines!!</font></a> <br />I started this blog to help get the word out that Home INR machines are NOT safe to use for patients with Antiphospholipid Antibody Syndrome. If you have APS, please read! Thanks!   <br /> <br /><a href="http://www.coaguchek.com/" target="_blank"><font color="#0066cc">CoagCheck Systems</font></a> <br />Literature clearly states that this machine has problems with APS patient and patients with the Lupus Anticoagulant. This is for the CoaguChek, CoaguChekS and CoaguCheckXS. Please call technical support at 800-428-4674 for more information. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them.   <br /> <br /><a href="http://www.apsfa.org/docs/Package%20Insert%20for%20CCk%20and%20CCkS.pdf" target="_blank"><font color="#0066cc">CoaguChek & CoaguChek S Strip Insert</font></a> <br />Literature clearly states that this machine has problems with APS patient and patients with the Lupus Anticoagulant. This is for the CoaguChek & CoaguChekS. Please call technical support at 800-428-4674 for more information. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them.   <br /> <br /><a href="http://health.groups.yahoo.com/group/APLSUK/message/49519" target="_blank"><font color="#0066cc">CoaguChek XS System - Patient Experience</font></a> <br />Registration Required to read story. "I called Roche and expressed my concerns about the reliability of the machine. They told me that at higher INRs (above 4.0) the machine becomes less reliable. They also told me that the machine doesn't work very well for people with Antiphospholipid Antibodies because these same antibodies are on the test strips! She said that especially when someone with APS is having a flare up the machine may not work well due to the high level of antibodies in the blood."   <br /> <br /><a href="http://www.apsfa.org/docs/XS%20Strip%20Package%20Insert.pdf" target="_blank"><font color="#0066cc">CoaguChekXS Strip Insert</font></a> <br />Literature clearly states that this machine has problems with APS patient and patients with the Lupus Anticoagulant. This is for the new CoaguChekXS. Please call technical support at 800-428-4674 for more information. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them.   <br /> <br /><a href="http://www.ajhp.org/cgi/content/abstract/62/18/1894" target="_blank"><font color="#0066cc">Devices for ambulatory and home monitoring of blood pressure, lipids, coagulation, and weight management, part 2</font></a> <br />Am J Health Syst Pharm.2005; 62: 1894-1903. Kelly L. Scolaro, Pamela L. Stamm and Kimberly Braxton Lloyd Copyright © 2005 by the American Society of Health-System Pharmacists.   <br /> <br /><a href="http://www.hemosense.com/docs/5500280_TechBulletin105_FactorsInfluenceINRCompsRevA.pdf" target="_blank"><font color="#0066cc">Factors That Influence INR system Comparisons</font></a> <br />List includes Antiphospholipid Antibodies. The APSFA does not promote, sell or make money from this company nor the vendors that sell them. However, if this document has been relocated again, please feel free to contact us for it.   <br /> <br /><a href="http://www.apsforum.com/forum25/forum25/6943.html" target="_blank"><font color="#0066cc">For those inquiring about HOME INR machines...</font></a> <br />Registration Required to read this patient experience. "You're putting your life into a machine that is KNOWN to be wrong with APS patients...think TWICE...THREE times...FOUR times and Just say NO!"   <br /> <br /><a href="http://www.apsfa.org/docs/FB5933_0307.pdf" target="_blank"><font color="#0066cc">Hemochron Jr. Package Insert</font></a> <br />Literature clearly states that this machine has problems with APS patient and patients with the Lupus Anticoagulant. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them.   <br /> <br /><a href="http://www.fvleiden.org/ask/94.html" target="_blank"><font color="#0066cc">Home INR Machines and Antiphospholipid Antibodies</font></a> <br />Home INR machines do not give accurate readings in about 1/3 rd of patients with antiphospholipid antibodies who are on warfarin. This is not due to the machine malfunctioning, but likely due to antibodies interfering with the test method of the home INR machines. In one third of patients with antiphospholipid antibodies the INRs read by the home INR machines are unreliable: (a) they either read too high, compared to INRs tested in a laboratory from an i.v. stick (reference 2), or (b) the instruments flash up an error message (reference 1). This inaccuracy is likely caused by the presence of the antiphospholipid antibodies. Since antibody levels can fluctuate over time, the instrument may give accurate readings at times when the antibody levels are low, but inaccurate ones at times when the levels are higher. This is a phenomenon not unique to the Coaguchek® instrument, but is also seen with the ProTime® and the INRatio® instruments (reference 1,2). In patients who do not have antiphospholipid antibodies the home INR machines give reliable readings and are a good way to monitor warfarin therapy (ref. 3). Last Updated: 8/22/06   <br /> <br /><a href="http://www.i-stat.com/products/ctisheets/715236-00H.pdf" target="_blank"><font color="#0066cc">i-STAT® PT/INR test</font></a> <br />The i-STAT® PT/INR test is a whole blood determination of the prothrombin time used for monitoring oral anticoagulant (warfarin) therapy. The test determines the time required for complete activation of the extrinsic pathway of the coagulation cascade when initiated (activated) with a thromboplastin. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. <br /> <br /><a href="http://www.nattinfo.org/NATT_Winter_07_08%20Newsletter_Final.pdf" target="_blank"><font color="#0066cc">INR Self Testing</font></a> <br />INRs from POC instruments are unreliable in about 1/3rd of patients with the clotting disorder called antiphospholipid antibody syndrome (APLA syndrome) who are on warfarin. In these patients, the POC devices give INR readings that are too high, or the instruments report error messages. This is the case with any of the 3 instruments on the market. If you have APLA syndrome, your INRs should be checked from blood drawn from a vein and tested in a laboratory.   <br /> <br /><a href="http://www.hemosense.com/docs/5500256_TechBull101_PatientVarInPT_RevC.pdf" target="_blank"><font color="#0066cc">INRatio by Hemosense</font></a> <br />Representatives & Literature clearly states that this machine has problems with APS patient and patients with the Lupus Anticoagulant. Please see: <a href="http://www.hemosense.com/docs/5500317_TechBull108_AntiPhospholipid_RevA.pdf" target="_blank"><font color="#0066cc">http://www.hemosense.com/docs/5500317_TechBull108_AntiPhospholipid_RevA.pdf</font></a> Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them. However, if this document has been relocated again, please feel free to contact us for it.   <br /><a href="http://www.hemosense.com/docs/5500259_TechBull104_InterferSubst_RevC.pdf" target="_blank"><font color="#0066cc">INRatio Monitor and Interfering Substances</font></a> <br />Anti-phospholipid antibodies can disrupt the phospholipid in the PT reagent that is necessary for the clotting reaction to occur thus artificially elevating the INR. The APSFA does not promote, sell or make money from this company nor the vendors that sell them. However, if this document has been relocated again, please feel free to contact us for it.   <br /> <br /><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=812419" target="_blank"><font color="#0066cc">MAUDE Adverse Event Report</font></a> <br />Caller alleged discrepant results compared with the lab. Results as follows: date: 01/12/07, inratio: 6. 1, lab: 3. 6. Ts updated this case on 01/18/2007 and 01/19/2007. 01/17/07, first test inr = 7. 5(old strip). Second test inr = 5. 5(new strip). Date: 01/19/07, inratio: 6. 5, lab: 4. 0. Caller has antiphospholipid antibody syndrome and recently had an episode of multi organ infection resulting in failure of adrenal glands.   <br /> <br /><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=992049" target="_blank"><font color="#0066cc">MAUDE Adverse Event Report</font></a> <br />Discrepant results (accuracy) comparison of inratio test with lab results provided by end-user at time complaint was filed: date: early 2007, inratio: 2. 1, lab: 8. 5, mean: 5. 3, confidence limits: unable to be determined. Per internal procedure, the mean of the inratio meter and comparative system inr were calculated. The confidence limits cannot be determined. The readings are considered inaccurate based on "area outside the acceptance region" table. The results are considered discrepant within the context of the documented variability for inr testing. Therefore, further testing is required at this time. In troubleshooting found that the pt has antiphospholipid antibody syndrome. It was explained that possible interferences may be due to the varying levels of the antibodies. Pts condition may cause the discrepant errors.   <br /> <br /><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=827524" target="_blank"><font color="#0066cc">MAUDE Adverse Event Report</font></a> <br />Discrepant results (accuracy) comparison of inratio test with lab results provided by end-user at time complaint was filed: date: 01/05/07, inratio: 6. 1, lab: 3. 8, mean: 4. 95, confidence limits: 2. 8-7. 2. Date: 01/15/07, inratio: 4. 3, lab: 2. 8, mean: 3. 55, confidence limits: 2. 2-5. 3. Per internal procedure, the mean of the inratio meter and comparative system inr were calculated. Both inratio and lab values are within the confidence limits for inr testing. The results are not considered discrepant within the context of the documented variability for inr testing. Therefore, further testing is not required at this time. Per text "pt has antiphospholipid antibody syndrome, (cardiolipin-positive, lupus-negative). " pt's condition may be causing interference.   <br /> <br /><a href="http://eyzrbrn.tripod.com/id20.html" target="_blank"><font color="#0066cc">My Experience with Finger Stick (Home) INR Machines</font></a> <br />Patient's story on her use of a Home INR Machine and supporting company information.   <br /> <br /><a href="http://www.hemosense.com/docs/5500317_TechBull108_AntiPhospholipid_RevA.pdf" target="_blank"><font color="#0066cc">Patient Variables in PT/INR Testing with INRatio</font></a> <br />Technical Bulletin from HemoSense makers of INRatio. Clearly states that APS effects its results. The APSFA does not promote, sell or make money from this company nor the vendors that sell them. However, if this document has been relocated again, please feel free to contact us for it.   <br /> <br /><a href="http://www.apsfa.org/docs/ProTime%20and%20APLA.pdf" target="_blank"><font color="#0066cc">Point-of-care testing of the international normalized ratio in patients with antiphospholipid antibodies.</font></a> <br />SL Perry, GP Samsa, and TL Ortel Thromb Haemost, December 1, 2005; 94(6): 1196-202. Antiphospholipid antibodies can influence the results of clotting tests in a subset of patients, which can be a major obstacle in monitoring warfarin.The aim was to determine if point-of-care testing of the International Normalized Ratio (INR) is influenced by antiphospholipid antibodies. Please note the manufacture of this machine helped fund this study.   <br /> <br /><a href="http://www.protimetest.com/" target="_blank"><font color="#0066cc">Protime Machine</font></a> <br />Representatives clearly state that this machine has problems with APS patients and patients with the Lupus Anticoagulant. Waiver for patients with APS must be signed. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them.   <br /> <br /><a href="http://www.apsfa.org/docs/IR5259_0307.pdf" target="_blank"><font color="#0066cc">ProTime Microcoagulation System Package Insert</font></a> <br />Literature clearly states that this machine has problems with APS patient and patients with the Lupus Anticoagulant. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them.   <br /> <br /><a href="http://www.coaguchek-usa.com/product_notification/index.html" target="_blank"><font color="#0066cc">Questions and Answers: For Use with CoaguChek® Test Strip Urgent Medical Device Correction (UMDC) 06-266 and Urgent Medical Device Recall (UMDR) 06-267</font></a> <br />11/16/06: CoaguChekS now has a 30% +/- acceptable standard of deviation.   <br /> <br /><a href="http://www.fdanews.com/newsletter/article?issueId=10981&articleId=100900" target="_blank"><font color="#0066cc">Thoratec Receives FDA Warning Letter, Plans Recall (ProTime)</font></a> <br />Thoratec’s International Technidyne Corp. (ITC) division has received an FDA warning letter citing concerns about its quality systems, specifically those related to certain lots of its ProTime System anticoagulation monitoring device.....of incorrect readings of patient blood coagulation levels.   <br /> <br /><a href="http://mdm.sagepub.com/cgi/content/abstract/26/3/239" target="_blank"><font color="#0066cc">Validity of Criteria Used to Evaluate Fingerstick Devices That Assess International Normalized Ratio</font></a> <br />Medical Decision Making, Vol. 26, No. 3, 239-246 (2006). Conclusion. The unvalidated criteria used to predict warfarin dosing agreement between 2 INR measurements are associated with large error. Warfarin dosing decisions should be measured directly in such assessments.<a href="http://www.apsfa.org/docs/APSFAVol5Spring2007.pdf" target="_blank"> <br /></a></p> Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com3tag:blogger.com,1999:blog-7232228941129431680.post-43981104348728813542010-02-03T19:02:00.001-08:002010-02-03T19:02:33.879-08:00More from Facebook<p>These are all from the <a href="http://www.facebook.com/apsfa/" target="_blank">APSFA Fan</a> page on Facebook. One of their members listed an <a href="http://www.associatedcontent.com/article/2608989/just_say_no_to_the_inr_finger_stick.html?cat=4" target="_blank">article</a> posted on Associated Content and that started quite a discussion!</p> <blockquote> <p><font color="#008000">I am glad to see this information posted on here. I have not started back on coumadin yet. But when I got my last test results and saw my B-2 glycoprotein titers went up I knew that it was coming. So I called my local coumadin clinic and asked them what I needed to do to become a patient. They specifically asked me the reason. When I told them they said that I could not use fingerstick machines. Granted they did not know why, but they did know enough to tell me absolutely not. And I am grateful because I was thinking about buying one in the future. </font></p> </blockquote> <blockquote> <p><font color="#000080">I utilized the machine Coagucheck and by an error of measurement I suffered a very serious clot. The machine gave me an INR of 4 and really was of 1.3. Now I control me puncturing me in vein.</font> </p> </blockquote> <blockquote> <p><font color="#008000">the finger stick machine was consistantly giving me too high readings, when my INR was actually dangerously low. Now my entire clinic has stopped using those machines for APS patients.</font></p> </blockquote> <blockquote> <p><font color="#000080">I appreciate you sharing this, I had no idea and have had regular testing at my doctor's office using a finger stick machine for years. Rest assured that I will be going in this week armed with these articles. Thank you!</font></p> </blockquote> <blockquote> <p><font color="#008000">They are a waste of money for APS patients. I got one and had to keep travelling to get my blood tested to compare for 3 months before I figured this out. I wish I had of known this 6 months ago. I did manage to get a full refund because they should probably ask you that when you order it. It took some fighting, thankfully I got it back. I was told a full refund the entire time and I made sure of that, they credited 400 dollars less back on my m/c so then I had to fight with them about that too, I was not impressed about that at all but the guy I dealt with took responsibility and helped me out. They are fully aware those machines don't work for APS patients so they should be asking that question before you ever order it and thats how I managed to actually get it back. So if it wasn't long ago-try again.</font></p></blockquote> Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com2tag:blogger.com,1999:blog-7232228941129431680.post-53969874016779161022010-01-24T14:14:00.001-08:002010-01-24T14:18:13.616-08:00On a Facebook Fan Page…<p>Ran across this on Facebook today. Poor guy suffered a clot because his machine was off. </p> <p>Maybe if he’d have known ahead of time, he could have avoided the inevitable wrong reading.</p> <blockquote> <p>I utilized the machine Coagucheck and by an error of measurement I suffered a very serious clot. The machine gave me an INR of 4 and really was of 1.3. Now I control me puncturing me in vein. </p> </blockquote> <p>That’s a HUGE difference. HUGE. 3.7 difference. 3.7 is some people’s therapeutic INR and there was that MUCH of a difference with this poor guy’s reading from his damn machine!! </p> <p>And that clot he suffered from could have been a stroke or a PE and could have killed him. </p> <p>Is it really worth the risk people? </p> <p><font size="2">Source: </font><a title="http://www.facebook.com/APSFA" href="http://www.facebook.com/APSFA"><font size="2">http://www.facebook.com/APSFA</font></a></p> Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com1tag:blogger.com,1999:blog-7232228941129431680.post-19570799570514553342010-01-17T15:50:00.001-08:002010-01-17T15:50:50.142-08:00New Source, Same False Readings!<p>A new forum popped into my reader today…and wouldn’t you know, there are a FEW threads about INR testing machines. Funny, I never found this forum before today.</p> <p>The next 4 posts are my findings from this new source…link is in most of the posts.</p> <p> </p> <p>Do they make you mad? </p> <p>They should. </p> <p> </p> <p>I don’t understand how people can still advise other people on how wonderful these machines are. They’re inaccurate. Plain and simple. </p> <p>What gets me is no one ever blames the company…they blame the time, the environment, the moon cycle…everything but the company. The company that we’re focused on in the following posts allows 10-30% error and still calls that “accurate”. </p> <p>Let me say that again. The company that makes these machines allows for 10-30% error and still calls that “accurate”. </p> <p>Does that seem wrong to anyone else. </p> <p>Do you want breaks on your car that may fail 10-30% of the time? Do you want to skydive with a parachute that is KNOWN to not open 10-30% of the time? Do you want to wash your hair with a shampoo that 10-30% of the time causes hair to fall out? </p> <p> </p> <p>Probably not. </p> <p> </p> <p>Yet, you’ll use a machine that could be wrong 10-30% of the time to test someone as important as YOUR BLOOD.</p> <p>Repeat that. Does it even make SENSE?</p> <p>People…the facts are in black and white. The truth is out there. Don’t be one of the 10-30% of people who’s machine fails them and results in a major bleed or clot. </p> <p>         Because that clot or bleed may be your last. </p> Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com4tag:blogger.com,1999:blog-7232228941129431680.post-7733008697457193852010-01-17T15:20:00.001-08:002010-02-05T21:42:28.007-08:00I Find My Machine Very ReliableSource: <a href="http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=8883">http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=8883</a><br />
<br />
…even though there is usually between 0.1 and 0.5 difference between a venous reading and my monitor…<br />
Read on people…read on.<br />
<br />
<blockquote><span style="color: #004000;">the" trombosedienst" (the nurses who check my INR) want to put me on self-management. There is a little problem. The self-management machine has not given a proper value of my INR. last time they tried ,the blood from the artery punction was measured as 2.1 while the machine gave a value 6.8 <br />
now here is the question: what kind of machines are you using for self-management and how precise are they?</span></blockquote><br />
<blockquote><span style="color: navy;">I use a Roche CoaguChek S monitor....I have successfully used a monitor since June 2003. I bought the new Coaguchek model last year and it has been even better than my old XS monitor. </span><br />
<span style="color: navy;">I find my machine very reliable and put my trust in it....and my life it is usually between 0.1 and 0.5 difference between a venous reading and my monitor. This could be due to a difference in the time that both tests are run. </span><br />
<span style="color: navy;">Hope that helps.</span></blockquote><br />
So, your machine is very reliable…and you put your trust and your LIFE in it…YET…it is usually OFF? and this is due to a difference in TIME? <br />
Seriously? Are you seriously telling me that you put your trust and your LIFE in the “hands” of a machine that’s usually WRONG??<br />
Oh, you’ve got to be kidding me.<br />
<br />
Source: <a href="http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=8883">http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=8883</a>Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com1tag:blogger.com,1999:blog-7232228941129431680.post-47490247800264458322010-01-17T15:11:00.001-08:002010-02-05T21:42:53.326-08:00Maybe The Machine is Dirty…Source: <a href="http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=9725">http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=9725</a><br />
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Hmm…maybe THAT’s why the machine is giving false readings…hmmm<br />
<br />
<blockquote><span style="color: navy;">I have been getting odd results from my machine, and have typically lost my handbook</span><br />
<span style="color: navy;">just found this from the roche website, it looks as if the way we have been told to clean it, is leading to incorrect results </span><br />
<span style="color: navy;">click here </span><a href="http://www.poc.roche.com/en_US/pdf/09-112_...XS_UMDC_PST.pdf"><span style="color: navy;">http://www.poc.roche.com/en_US/pdf/09-112_...XS_UMDC_PST.pdf</span></a></blockquote><br />
<blockquote><span style="color: #004000;">Thanks …… i have been having the same problem...will give it a try</span></blockquote><br />
<blockquote><span style="color: navy;">where do you get your alcohol from?</span></blockquote><br />
<blockquote><span style="color: #004000;">i just used water...but its still not correct...5.5 at home and 6.1 at the clinic !</span></blockquote><br />
So maybe if we all get our alcohol from the same store on the same day within the same timeframe then our machines will FINALLY give us a correct reading!!!<br />
Hahahaha….WRONG WRONG WRONG people!! THE MACHINES DON’T WORK CORRECTLY FOR APS PATIENTS!!!!!!!!!!!!!!!!!!!!!!!!!!!<br />
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Source: <a href="http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=9725">http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=9725</a>Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com2tag:blogger.com,1999:blog-7232228941129431680.post-89979095038115993192010-01-17T15:05:00.001-08:002010-02-05T21:43:29.586-08:00Coag XS MachineSource: <a href="http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=8883">http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=9796 </a><br />
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This will blow your mind!! I don’t know if it’s ignorance, or what the heck is going on, but wait till you read this. I will put my comments at the end. This blows me away. The different colors are just to separate the posts from each other.<br />
<blockquote><span style="color: #0000a0;">Can u hear me screaming ! </span><br />
<span style="color: #0000a0;">Had inr Clinic this afternoon...my machine said 5.3...the clinic 7 !!! </span><br />
<span style="color: #0000a0;">so just rang Roche their trying to tell me because the clinic doesnt use their machine and its a differant make that my inr wont tally...well what good is that to me confused.gif </span><br />
<span style="color: #0000a0;">I told her my machine is pretty much spot on apart from these last few weeks.... </span><br />
<span style="color: #0000a0;">I wouldnt have bought a machine i said if it wasnt to give me readings i mean for goodness sake do they tell u that unless the clinics meachine is their make then we wont get a correct inr grrr...shes speaking to her supervisor and calling me back....</span></blockquote><br />
<blockquote><span style="color: #004000;">(sorry) to hear that you are having trouble at your inr clinic.</span><br />
<span style="color: #004000;">I have much the same trouble when I go to the surgery to have my blood pressure checked. I get the impression that they do not like us doing things ourselves.</span></blockquote><br />
<blockquote><span style="color: #0000a0;">It is quite common to get different readings from different machines... <br />
My hemos office uses the pt/inr/ratio one and it is different from the vienous draw at the hospital. I do have the LA so that may be why? Do you have the pos lupus anticoagulant? I would not blame it on Roche... it seems to be a common issue from what I know on other home testing machines as well. <br />
But i do know how frustrating it is. I am waiting for the day that we wont have to test...hope its in my lifetime!</span></blockquote><br />
<blockquote><span style="color: #004000;">mines playing up at the moment, too ……, but i am wondering if i am having antibodies that i don't normally have? cos thats when the readings can go wrong i think, is that right?</span><br />
<span style="color: #004000;">I am going to contact Roche tomorrow and see if they can help any. I have tried different test pots and that but havent cleaned it yet, as i am going to ask em where to get the alcohol from, did get the vodka but drank it hehehe! (no not really, never drunk vodka actually!, drank lots of other stuff though) </span><br />
<span style="color: #004000;">will let you know how i get on, hope they can help us both, is yours still under guarantee?</span></blockquote><br />
<blockquote><span style="color: navy;">That's frustrating, (name-removed), but I think it would be good to get the machine checked against a number of blood samples. A one off doesn't really tell you much, and who's to say it's not a hospital error with your sample? </span><br />
<span style="color: navy;">I self manage, so never know what a clinic test would say in comparison to my machine. Makes me think that maybe I should do the occasional comparison. </span><br />
<span style="color: navy;">I do remember that Roche have always said that people with a +ana need to be aware that they may have inaccurate test readings... It's all rather an inexact science, isn't it? </span><br />
<span style="color: navy;">Do let us know what they say.</span></blockquote><br />
<blockquote><span style="color: #004000;">well seems the girl was calling me from a call centre in Germany ! </span><br />
<span style="color: #004000;">Spoke with …… who has given me a phone num which i have called and left a message. </span><br />
<span style="color: #004000;">The girl panicked me by saying oh how high it was etc etc and if i need to call an ambulance...than when i said it had been 10 she almost fell off her chair i feel sure i heard a thud </span><br />
<span style="color: #004000;">if she had spoken to someone who is not familiar with an high inr she would have scared them for sure. </span><br />
<span style="color: #004000;">don't get me wrong …… i am not blaming Roche just saying that i was given confusing information. </span><br />
<span style="color: #004000;">My machine as always been spot on when checked against the finger prick at the clinic. </span><br />
<span style="color: #004000;">…… anti bio do make a diiferance to our inr... </span><br />
<span style="color: #004000;">anyway hopefully going to have a venous test tomrrow so will let u know how it goes</span></blockquote><br />
<blockquote><span style="color: navy;">I was also told that the hospital tests (vienous) are always slightly different to the finger prick tests....don't know why.I have found mine is usually the same... <br />
I have found Roche are pretty good and the machines are usually quite accurate. <br />
I hope todays test will go ok .....I know you havent been to well for a few weeks...maybe Ally could be right...some different antibodies that could be cocking up the result?</span><br />
<span style="color: navy;">Let us know how you get on</span></blockquote><br />
<blockquote><span style="color: #004000;">could you send me the number to call cos i think he was probably German or certainly had an accent of foreign kinds! bet i have called the same number. </span><br />
<span style="color: #004000;">my inr is just dropping so maybe it is the antibiotics, thanks honey, totally didnt think of it </span><br />
<span style="color: #004000;">its great this site eh, we keep each other going eh</span></blockquote><br />
<blockquote><span style="color: navy;">thanks chick, but they have just called me </span><br />
<span style="color: navy;">I am going to get 90 % isopropanol (sp) or 96 % ethenol to clean it first, then if its still giving way out readings, they are going to send me a new machine. </span><br />
<span style="color: navy;">He was lovely (calling from Germany) and said if the range is 2.0 to 4.5 then they work on the thing that between 10 % to 30% difference is acceptable for the machine, but as mine is much more different, then that is unacceptable. </span><br />
<span style="color: navy;">So sounds fair to me, will clean it and see what happens next smile.gif </span><br />
<span style="color: navy;">and hope your venous samples ok chickie, i have mine done everytime like that at the hossie too</span></blockquote><br />
<blockquote><span style="color: navy;">they have just called back again, to say they want me to use some strips that they are going to send me, at the hospital at the same time as the venous bloods taken. and to test at the same time with my old strips too. </span><br />
<span style="color: navy;">then record the results and phone them with what they are. </span><br />
<span style="color: navy;">so will see what happens next!?</span></blockquote><br />
<blockquote><span style="color: #004000;">i have received the test strips today and my inr with the new ones is 3.8, test with the old one comes up at 3.4, 3.2 so am wondering if it could be my test strips?</span><br />
<span style="color: #004000;">the code i have at the mo is 267, wondering if yours is the same batch?</span><br />
<span style="color: #004000;">p.s.! i found another box of strips which are a different code and they are testing me at 3.7 so thats what makes me think its probably those strips which are cocked up!</span></blockquote><br />
<blockquote><span style="color: navy;">wonderful news that you have gone to all that effort honey...sometimes it pays off to just do a few more comparison tests. <br />
good news that Roche sent you out the other strips to try.......and had offered a new machine if the problem had still be there. <br />
…… hope you manage to get the probs with your machine all sorted.....check the strips like …… mentioned</span></blockquote><br />
<blockquote><span style="color: #004000;">update... </span><br />
<span style="color: #004000;">new test strips and chip and its still out. </span><br />
<span style="color: #004000;">Hospital test from yesterday 4.1...mine 4.9 </span><br />
<span style="color: #004000;">so just spoke to them and their sending me a brand new one !! should get it in 3-5 days also a jiffy bag for my old one wow...what service is that !! </span><br />
<span style="color: #004000;">my inr mon was 7 and 4.1 yesterday ...but i missed a dose mon ...it had to be done... </span><br />
<span style="color: #004000;">it was horrid yesterday...they took my blood then just let it come out to take some for my machine yuk made me all quesy !! </span><br />
<span style="color: #004000;">inr clinic later today</span></blockquote><br />
<blockquote><span style="color: navy;">omg! really they did that! yuk!!! <br />
glad they are sending you a new machine</span></blockquote><br />
<blockquote><span style="color: #004000;">hiya what number did you call please hunny? <br />
they are saying that 1.0 is ok for the machine to be out, and that they are different readings to the hospital inr <br />
apparantly its like comparing celcius to farenheit? <br />
dead confused!</span></blockquote><br />
OK…did you make it through all of that mess? Sorry about the spelling and the language…I believe most of the members of this forum are from overseas and they talk well…you read that mess, right? Anyway…let us review. <br />
So the machine is off…the person asks on this forum…is given a number of reasons why it could be off…antibodies are different, +ana, the machine is dirty? (that’s a new one…and I have more on this!), the strips are different…etc. BUT…they NEVER blame the company!<br />
The company KNOWS these machines don’t work with APS patients. They have it in their literature. READ THE PAPERWORK, people!!! They say that ppl with a positive ANA may have false readings…but hey it is ok for you to use with your APS?! And no comparison...so how do you even know it is accurate?!<br />
Hell, how do you EVER know it’s accurate unless you do comparison draws every.time.???<br />
<br />
Source: <a href="http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=9796">http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=9796</a>Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com3tag:blogger.com,1999:blog-7232228941129431680.post-11511314173329272282010-01-17T14:51:00.000-08:002010-02-05T21:44:47.606-08:00And the Kicker…Source: <a href="http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=5477">http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=5477</a><span style="font-size: x-small;"><br />
</span> <br />
<br />
This forum advertises for these machines. I mean, there’s an actual post on this forum with a link to the manufacturer and a phone number to call if you’re ready to “gain more independence”…yeah, that and risk your life on a daily basis by checking your INR with these INACCURATE machines! Can you believe they actually ADVERTISE for these? They tell you there are problems…they’re “usually” off by whatever margin…yet, they put their LIVES in the hands of these machines. <br />
<br />
<b><span style="font-size: large;">And they’re trying to sell them to you.</span></b> <br />
<br />
<blockquote><a href="http://www.coaguchek.com/uk/index.php?target=/en/patients/self_monitoring" target="_blank">CLICK HERE TO VIEW THE ROCHE WEBSITE</a><br />
<b>Self-Monitoring</b><br />
Choose independence <br />
Has your doctor just told you that from now on you need to use oral anticoagulant drugs, and that the clotting times of your blood will have to be checked regularly?<br />
Oral anticoagulation therapy is necessary if you have an artificial heart valve, or if you are affected by atrial fibrillation or thrombotic diseases. Taking an oral anticoagulant or "blood thinner" is very important for your health. It is important for the dosage to be exactly right. This requires regular monitoring, as people react differently to those drugs or as several factors may interfere with it e.g. food, other drugs, etc.<br />
This monitoring, after being released from the hospital, usually takes place at your doctor's or in an anticoagulation clinic. It traditionally requires a blood sample being drawn from a vein at a doctor's office or at a private or hospital lab/anticoagulation clinic. It results in commonly long waiting times and potential time losses i.e different appointments, which reduce your independence.<br />
However, recent developments are now allowing patients to monitor medication themselves. This is so called Coagulation Self-Monitoring. Self-Monitoring has many advantages: it is straightforward, it makes routine testing easier, it gives your independence back and it means you can be directly involved in your own health, collaborating with your Healthcare Professional. Even more important, experience has shown that more frequent testing reduces complications resulting from the underlying disease or from the anticoagulant itself.<br />
With the CoaguChek XS or S system, we can help you to get back to a lifestyle as independent and as safe as possible, based on our more than ten years experience in helping patients monitoring their coagulation status - anywhere and anytime.<br />
The information provided on this website will answer many of your questions. Be sure to ask your doctor or Healthcare Professional if you have others.<br />
Go for more independence and safety! Choose Coagulation Self-Monitoring!<br />
<br />
<b>Self-Monitoring: Self-Monitoring at home</b><br />
CoaguCheck S system for home monitoring <br />
The CoaguChek S or its successor, the CoaguChek XS system, is a device which allows you to manage your own oral anticoagulation therapy at home. The method is known as Patient Self-Monitoring.<br />
The CoaguChek XS or CoaguChek S is a portable, easy to use and battery-powered monitor that provides accurate readings quickly and easily. These systems are used successfully by doctors and health care professionals in anticoagulation clinics, and also by patients undertaking Coagulation Self-Monitoring (or even Self-Management), after a proper professional training.<br />
Self-Monitoring has the benefit of being accurate and can be reproduced, as results are never affected by variations in test methodology or different laboratory environments. Each test result can be compared directly with previous tests. This means that you and your doctor are always fully aware of any changes and drug dosage can be adjusted appropriately.<br />
Using the CoaguChek system for Self-Monitoring at home is simpler than travelling to an anticoagulation clinic, a lab or to your doctor's office. A busy schedule needn't be interrupted and there are no transportation or logistics problems for people having a difficult access to healthcare facilities. The system is accessible at any time and can be used whenever and wherever needed. Thereby the CoaguChek XS strips can be stored at room temperature for a long time.<br />
You gain more independence!<br />
<b>Where to Buy</b> <br />
For more product or support information, or if you wish to proceed and purchase a CoaguChek XS system please call our CoaguChek Careline free on: 0808 100 7666</blockquote><br />
<span style="font-size: x-small;">Join…see for yourself. <a href="http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=5477">http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=5477</a></span><span style="font-size: x-small;"></span>Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com1tag:blogger.com,1999:blog-7232228941129431680.post-27622729963969494682010-01-02T09:28:00.000-08:002010-02-03T17:54:55.453-08:00New Year…Same Song<span style="font-family: ari;">The following is a conversation between members of a well known Yahoo group. (link at the bottom). This is kind of a long post, but it does show both sides. </span><br />
<span style="font-family: ari;"></span><br />
<blockquote><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">I am post op and there's been some "difficult" communication between hematology and surgeon, so agreed to hematologist who monitors with no INR machine on site. It's an oncology center, the other hematologist sent me to Cardiac Center. My surgeon, a GYN says the INR machines are not nearly as accurate as doing the full lab (from blood draw from vein). Is that the consensus in medical community? Oh, and before anyone suggests I see a rheumatologist, I am in a part of the country where I believe I can safely say the rheumatologists are ENTIRELY unaware of APS being the realm of Rheumatology, even when I bring in Dr. Hughes publications and tell them about the very first podcast in the Oxford JOurnal of Rheumatology (they send table of contents to mailbox free for creating a login, and then sometimes TOC links to something really good like the podcast a few months back. I simply get blank stares and referred to hematologists who are primarily oncologists, even though they believe they are fully aware of APS, the hematologists I've met here (3) firmly (let me emphasize FIRMLY) believe that APS is asymptomatic, and if they aren't going to listen to their own colleagues in other parts of the world, why would they listen to a 'mere' patient like me? It's very draining to try new doctors, hear them say they know all about APS, and yet no nothing of the discussion content here in this forum or in the International Community. I guess few decades behind.</span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;"></span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">Right now I am having bleeding because my INR got to 3.9, and pain with it, which I am not sure is from the laparoscopic total hysterectoy (took ovaries too). </span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;"></span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">So, dear group, what is your believes on INR accuracy and, when in geographic part of USA that hasn't a clue APS belongs in Rheumatology, where is the next best place to be monitored: a cardiac center with an INR machine or an oncology center that doesn't own a single INR machine.</span></div></blockquote><span style="font-family: ari;">She asks a question about machine accuracy…because her surgeon brought up that they are “not nearly as accurate” as a vein draw. Good question! However, you need to ask that question somewhere where people are going to give you an answer that is FACT and backed up with PROOF. Not personal experiences. </span><br />
<span style="font-family: ari;">Here’s the answers she got:</span><br />
<blockquote><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">I am now on my second Coagucheck machine and as far as I am concerned, their use has not only been of immense convenience but has probably saved my bacon on a number of occasions.</span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;"></span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">I had a bit of a fight to get my first Coaguchek X but when I arrived at the surgery after rehearsing my arguments, the doctor said she had changed her mind as her father had started using one. It was agreed that I would have periodic checks through the surgery/lab tests, to see how they compared with my own home testing. There has never been more than 0.2 difference, more often less. The makers of the equipment say that a small difference is not unexpected.</span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;"></span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">The NHS pay for my strips, I bought both machines. I went on to the XS updated version because it was smaller, and the strips do not have to be kept in a fridge. Also with arthritis in my hands it is easier to use.</span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;"></span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">I recently had to have some teeth extracted and I needed to have my INR not much above 3.0 They didn't want to rely on my results and brought out their own machine - an older Coagucheck X! Their result mirrored mine exactly.</span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">I know of some surgeries that use the Coagucheck machines for routine INR tests so the word is spreading slowly.</span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;"></span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">Roche do indeed say that in some cases the machine may not be suitable for APS patients. Because of this Roche let me try one for several months to make sure I was suitable and would get consistent results. I did.</span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;"></span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">When I saw Prof Hughes privately recently, he was very pleased that I was using the coagucheck machine and encouraged me to check my blood every two days or so. That would be impossible without home testing if I wanted a life- and a real pain for my surgery. Following my closure of PFO procedure my coagulation has been monitored even more closely in the first instance - I am sure all at my surgery were very pleased to be able to know how my INR was behaving just by ringing me. Fotr me, having a result in minutes is far preferable to waiting for up to a week (by which time it can be too late) It has been proven accurate and allows me to get on with life.</span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;"></span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">I am aware that the accuracy is not the only issue, there are politics involved and issues to do with letting patients have some control. At the moment I am perfectly competent at taking the test and working out what dose of warfarin to have. Not all are so fortunate. Encouraging more to self-test would have an effect on lab budgets!</span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;"></span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">On the subject of self testing vs lab testing, one important factor is what happens with the results. Many surgeries use a computer program called INRstar. To my mind it is potentially the most dangerous aspect of INR testing. If you are self testing then I suggest that you either get out of the INRStar system and work out your own doses, or if you cannnot, then you make sure that your surgery feeds in the right data every time (this can be tedious for them). Assuming, incorrectly, that you have taken the dose that the INRstar program suggests can lead to inappropriate suggestions for future doses. They say garbage in garbage out but nothing in can also mean garbage out.</span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;"></span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">Finally, on the question of Heamatologist vs Rheumatologist, I guess it depends on the individual doctor. I've stopped seeing the haemotologist, we had different ideas on what was expected from the relationship- he considerd his role was just to monitor my INR. He had not accepted my argument for an INR above 2.6 even after being given Dr Khamasta's paper that advised people with my history should be above 3.0. Whe the stroke consultant upped it (after three TIAs) he used the same study to justify the raise. The Lupus unit at St Thom's (where Prof Hughes was) seems to be made up of Rheumatologists from what I can see - that tells you something.</span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;"></span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">I know Clair that my experience is of the UK but hopefully it may be of help. I have spent about £750 buying my two machines (and got back £100 selling the first on EBay)and I get the strips, (which are about £2 odd a time), free but, if push came to shove, I would finance the whole thing myself if I had to. With my medical history, my life depends on self-testing as far as I am concerned.</span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">It does seem to me that doctors who know much about APS support the self-testing for those who can manage it.</span></div></blockquote><span style="font-family: ari;">“My life depends on self-testing”? Really? You’re not giving your life much of a chance. Why would you play Russian Roulette with your life and these machines that just are NOT accurate for APS patients. Wait though…the great Dr. Graham Hughes was pleased! woo hoo! Well there’s a reason to risk your life since your machine has never been more than 0.2 off…most often less. Whoop de doo. Do you do vein comparisons EVERY TIME you use your machine? Wait…no, you don’t? WELL HOW DO YOU KNOW THEN???? UGH!</span><br />
<span style="font-family: ari;">and:</span><br />
<blockquote><span style="font-family: ari;">I can only speak from my own experience but I've had way more accurate readings when a vein was tapped and the blood sent to the lab than trying the handheld INR machine. I assume that's the machine you're referring to? I tried the handheld INR machines and got wildly inaccurate readings when I tested along with the blood draw in the lab (i.e. INR Machine said 6.1 and the vein draw said 2.6, huge difference). </span><br />
<span style="font-family: ari;">Where do you live? I'm in Washington DC and am seen/treated by the heads of hematology at two hospitals here. Is there anything I can do?</span></blockquote><span style="font-family: ari;">Thank you,….you ARE correct!! </span><br />
<span style="font-family: ari;">Another sensible answer: <br />
</span><br />
<blockquote><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">I just started warfarin a few months ago and have yet to have a match between INR machine and vein stick. They've been off as much as .5. So I tell the dr I want to continue with vein sticks. I explained that the Coagcheck machine says IN THE DIRECTIONS that it is not accurate for APS patients. The reagent used on the test strips interacts with APS antibodies and produces inaccurate results. I doubt seriously that I'll ever home test, unless the manufacturers of the machines figure out how to make them accurate. I have three kids to raise, I'm not taking any chances with my health.</span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"></div><br />
<div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">I'm in Memphis TN. I haven't had too much of a problem finding good doctors who understand APS. But my first hemotologist refused to try anticoag treatment for symptoms outside of pregnancy. So I went to another one, who I just love. She's terrific. She's also a cancer doctor. I don't think there are any hemotologists here that aren't cancer doctors. My symptoms are primarily neurological, so I don't need a rhuematologist. I may eventually end up seeing a neurologist, but so far, I've been stable. I found out about my APS after three miscarriages. I got treatment and had identical twin girls in April. </span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"></div><br />
<div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">I hope you get it figured out and find a good doctor. It makes a huge difference haven't doctors who understand the illness.</span></div></blockquote><span style="font-family: ari;">*eyeroll* on this next one…OFF is OFF people. How do you know what percentage it’s off…this isn’t a CONSTANT…it VARIES!!! <br />
</span><br />
<blockquote><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">I have the Coaguchek XS (Roche) INR machine which I bought in 2008. For several weeks I had the chance to compare results from lab and the machine, with blood collected for both tests with no more than one hour difference.</span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><br />
</div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">What I can tell is that in my case, and this can be different from person to person, machine and test strips calibration, results were pretty accurate when INR ranged between 1 and 4, with less than 5% error. If INR was above 4, error was of the order of 10%, but still gave a direction that things were not right and needed adjustment. I haven't been requested to take any lab test since late March this year and am relying on my machine results only and on a balanced diet to keep the same dosage. Doctors in San Antonio, Texas, seem to rely on results from these machines too.</span></div></blockquote><span style="font-family: ari;">Another response. I don’t understand how if it is inaccurate at all how anyone can trust what the machine says! Are you doing comparisons 100% of the time? That’s the ONLY way to know if your machine is accurate…BECAUSE THEY AREN’T for patients who have APS!!!! <br />
</span><br />
<blockquote><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">Hi, there is a real problem with both laboratory, clinical level machines and the home test machines. The problem is that all machines currently in use use the Prothrombin Time Test (PT) or the activated PT (aPTT), which can produce a false high reading on 20% of the patients who have active Lupus Anticoagulant test results. When these 20% have lower antibody activity levels the machines will read perfectly normally, however it is difficult to know if it is a high INR or a false high reading as the LA test is virtually never done at the same time and with the same blood draw, so the proof is very difficult to know whether the result is accurate or if the INR is high.</span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"></div><br />
<div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">Laboratory tests will also rely on the PT or aPTT and will also give the same false high under the same circumstances. Patients with 'known' LA activity have to have their anticoagulation tested by a totally different method and the laboratory will have to be told that the patient has active LA for them to break away from their normal test procedure. If the laboratory is told the patient has APS, it is not enough information for them to carry out different tests, they have to be told exactly that the patient has high LA. Remember the laboratory staff are not doctors and have full training in the machines and test procedures but rely on the doctors asking for the right test, or else they just stick to the tests corresponding to the colour of the top on the blood test vial.</span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"></div><br />
<div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">I do have active LA at times of a flare in my APS, and that has caused false high INR readings from my Roche Diagnostics CoaguChek machine, which agrees with every lab test I have ever had done (to within 0.04 of a variance as the home machine will round up or down to one decimal place). In these cases I am usually quite ill, so I assume the result to be high and carry out retests for a few days until I can be sure the INR is high (and not false high) before changing my Warfarin doses. This has happened twice this year and the first time the INR corrected itself after three days and the second time (last Sunday) I had to change my dose by about 25% for a couple of days before the INR returned to normal.</span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"></div><br />
<div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">I hope this helps a little in understanding how my machine can be accurate 50 times this year (out of 52 tests) and was 100% accurate for the last nine years compared to three times a year correlation laboratory tests.</span></div></blockquote><span style="font-family: ari;">And for the last one…let’s not blame the machine, let’s blame the antibodies. *smacks head* When will people learn? <br />
</span><br />
<blockquote><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">I'm so sorry for everything that you are going through. I completely understand what you are saying it seems as if you can add Tennessee to your list of doctors who won't go the extra mile.</span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;"></span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">As for the the INR machines - well I had a machine some time in 2002 and it kept giving me error messages because of my antibody levels. This past year at the Army base I was getting my blood checked there with a machine (and lab for the 1st couple of times) and it was pretty much on point. They might have worked out most of the kinks with the new models. My doctors keep my INR between 3 and 4 so if a tech doesn't know that they might think it to be an error. Personally I have really small, hard to find veins so the machine was a relief for me.</span></div></blockquote><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">What a relief to be using an inaccurate machine because it saves me the vein draw in my very tiny, hard to find veins. </span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;"></span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;">People, people, people…have we not learned ANYTHING. Do you need more proof, more facts? Click on my links on the right. There’s your PROOF. </span></div><div class="MsoPlainText" style="margin: 0in 0in 0pt;"><span style="font-family: ari;"></span></div><h6><span style="font-family: ari;">All quotes taken from APLSUK & APS-SYNDROME…both yahoo groups.</span> Happy reading!</h6>Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com2tag:blogger.com,1999:blog-7232228941129431680.post-9179493020766800512009-09-27T14:14:00.001-07:002009-09-27T14:30:34.627-07:00A Conversation on YouTube<p>This was a conversation in the comments section on YouTube. The original poster has since deleted their comments, but the other person saved the entire thing in their YouTube in and outbox. </p> <p>The conversation took place in early June and then late July. </p> <p>It’s a little long, but worth a read. </p> <p><strong>Person A will be bolded and they are the original poster.</strong> </p> <p><em>Person B is the other person who saved the conversation and their parts will be italicized.</em> </p> <p>-----------------------------------------------</p> <p>A little background. Person A’s wife has APS and they were getting their INR drawn using a fingerstick machine. Since the machine was off, they were subtracting 0.8 from the number that the machine read. </p> <p>Now you all know how I feel about having to subtract…what if it’s not correct that day? 0.8 may not seem like a lot, but it’s the difference between being fine or having a stroke in some cases! </p> <p><font size="1">Some text has been removed to protect the identities of both parties.</font> </p> <p>--------------------------------------------------</p> <p><u>Person A:</u> </p> <p><strong>OK, now i can receive info on specific articles that clearly say don't use finger stick inr units...?? <br />I understand that aps greatly introduces error into even the hospital readings.....depending on the thromboplastin reagents used.....so the concept that there is an accurate inr is itself perhaps an error.......chromogenic factor X and factor II testing seem to be the least variable of all measures of anticoagulation......DO YOU KNOW IF YOUR LAB USES THESE TESTS? If not, i think your tests may not be that much more accurate than the finger stick....I wish i knew how to get ahold of the inratio company....do you have phone number for them??? I am sure they would fess up to inaccuracy of the unit with aps....but science and engineering deal with measurement inaccuracy on a daily basis.....and this is science make no mistake. I am not naive enough to believe that my method is right for everyone.....we are not new to aps and so far we have had few mishaps. This is why we drive to Birmingham to see hematology, because we weren't satisfied that anyone in Pensacola understood APS....sad but true. Also , my wife had recent mitral valve implant...so I totally understand the severity and necessity of accuracy and immediacy of these readings. If you have info on Inratio units , I am all ears!</strong></p> <p><u>Person B:</u></p> <p><em>My hospital compares my hospital vein drawn INR to a Factor X every six months. It always matched but my the finger stick machine I owned was off. We would check the Factor X when my finger stick machine was very off .5 or greater and compare it to the hospital vein draw and Factor X. The hospital vein draw and Factor X were the correct numbers. So, no the finger stick machine was off… (they added a bunch of links as well)</em> </p> <p><u>Person A:</u></p> <p><strong>according to Ortel and Moll Annals of Internal Medicine....1 Aug 1997...APS patients should not be followed with INR at ALL.......this goes back to my assertion that your hospital values may not be any better than the home unit....Some heavyweights in hematology need to weigh in on this subject.....I will take this up with UAB and local hematology. Having problems with a measurement doesn't necessarily invalidate the entire modality for all patients. face it : there is no accute test from what i am reading.</strong></p> <p><u>Person B:</u></p> <p><em>Here is the information on INRatio: <br />http://www.hemosense.com/patient/pt_inr.html and there technical bulletin: Representatives & Literature clearly states that this machine has problems with APS patient and patients with the Lupus Anticoagulant. Please see: http://www.hemosense.com/docs/5500317_TechBull108_AntiPhospholipid_RevA.pdf Those using this machine should be getting vein draw comparisons at least every 6-8 weeks…(information removed)… <br />Along with the substances that interfere: http://www.hemosense.com/docs/5500259_TechBull104_InterferSubst_RevB.pdf <br />Ask them point blank if your wife should be using this machine with APS. Tell them you are subtracting 0.8 from the machine reading and see what they say. Ten to one they will ask you for a mess of information to report it to the FDA and tell you to stop using the machine.</em></p> <p><u>Person A:</u></p> <p><strong>Well, i did get someone on the phone at hemosense and they did indicate that they are not advising aps patients to use their unit......i might observe that you really have to dig to get this information.....and then this leaves you dependent on perhaps a just as error prone test in the er after waiting 8-10 hours.....the more i read, the more i don't see how anyone can really trust these readings.....only a major university lab is equipped to do the best tests at least that is my guess.....so good luck !! <br />Are any on the list being anticoagulated with Arixtra?? new drug factor X inhibitor.....no monitoring needed i think.......not strong enough for my wife since she needs high inr.....b ut may eventually work for some aps pts???</strong></p> <p><u>Person B:</u></p> <p><em>So, my information was correct. <br />Yeah, there are some who are on Atrixa after they have failed Lovenox. The bad thing about Atrixa is it is not approved for long term use and there is no way to reverse it if there is a medical emergency other than time. Like other LMWH, it is also horrible on your bones.</em></p> <p><em>But my Factor X and Factor II matches my vein draws. <br />Read the information from the manufacture of the machine, please.</em></p> <p><u>Person A:</u></p> <p><strong>only one of our hospitals here in town does in house factor X.....we are changing hospitals now......and may wind up with a new crop of docs as well....if the companies could change the make up of their test strips for aps patients it would seem that this might make the tests more accurate...but only bad publicity will force them to do this....inratio patient printed info was not very informative ....by phone i did manage to get some answers....I guess we wanted to believe that home monitoring was going to work as advertised......when you say "vein draws" you mean plasma based assay?? plus factor X and II.. <br />Thanks</strong></p> <p><u>Person B:</u> </p> <p><span><em>Yes, I mean regular vein draws that are put through a real machine. This companies hide this information because bottom line is they want to sell the thing. The person who answered your question had to answer it because you aske a point blank question that if they didn't answer they would be in trouble with the FDA for. Unless these specific questions are asked patients are not verbally disclosed this when they purchase these stupid machines. Same thing when they sell them to the doctors offices. It comes down to bottom dollar. <br /> <br />No, she shouldn't need all new doctors, just a lab that will do normal vein draws. My Factor II and Factor X are shipped out - they are only done once or twice a year. You will probably find out that her normal vein draw is the accurate number anyhow once they do the Factor X and Factor II comparisons and not need to do that anymore. Her current doctors, if they are good, should be willing to work with a different lab. Though, not sure why you are driving 250 miles one way on a regular basis for regular care, when a local doctor can work with the care plan that has been set up by her team there and she goes there once or twice a year for follow up. Just an idea. <br /></em></span><span> <br /><em>The companies are not going to change the strips for APS patients. We are not the majority of their cliental. We have a rare disease. Their cliental is heart patients, valve replacement patients, etc. We are the minority and until the majority starts having issues with these machines they will not be fixed. <br /> <br />My next suggest is to call the FDA and file a report on the errors you have been having. The FDA has been trying to force them to have better accuracies. Since we have been speaking out about these issues, more and more people have started reporting the differences which is waking up the FDA. Funny thing is we are finding they are just not APS patients. <br /> <br />So, please file a report, then call INRatio that you filed a report with the FDA. This tells them you mean business. This is a life and death matter. <br /> <br />Good luck</em></span></p> <p><u>Person A:</u></p> <p><strong>I would like to say that your efforts have helped and also that this last note should be prominantly displayed on the web sites.....I have a feeling that too many are having problems finding the pertinent information and extracting it from the medical texts....</strong></p> <p><u>Person B:</u></p> <p><em>It is on the internet, it is searchable. …(information removed)…  <br />When I was using that machine I needed to be at 4+ to feel ok and was clotting at those INRs - well those numbers were WRONG....they were false high. <br />Now that I am on vein draws only, my INR has been dropped to 2.5-3.5 and I feel great at 3.0. And I know those are accurate because when there is a new batch of regents they test my Factor X and Factor II and they match the vein draw. <br />It is the finger stick machines. There are tons of documented incidents of these finger stick machines reading wrong. <br />0.8 is really a HUGE difference.</em></p> <p><em>-------------------------</em></p> <p><font size="3">Then Person A came back a couple days later with the following information. This is still all in YouTube comments.</font> </p> <p>--------------------------</p> <p><u>Person A:</u></p> <p><strong>MEDWATCH problem reporting ....MAUDE database : <br />Manufacturer and User Facility Device Experience (MAUDE) Database ... <br />... variability for inr testing. Therefore, further testing is not required at this <br />time. Per text "pt has antiphospholipid antibody syndrome, (cardiolipin-positive ... <br />www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=827524 - 19k <br />MAUDE Adverse Event Report <br />... Second test inr = 5. 5(new strip). Date: 01/19/07, inratio: 6. 5, lab: 4. 0. Caller <br />has antiphospholipid antibody syndrome and recently had an episode of multi ... <br />www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=812419 - 32k <br />Manufacturer and User Facility Device Experience (MAUDE) Database ... <br />... variability for inr testing. Therefore, further testing is required at this time. <br />In troubleshooting found that the pt has antiphospholipid antibody syndrome. ... <br />www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=992049 - 21k <br />You and your troops need to report more discrepancies....there is an online reporting form i believe. I just found this tonight, but i will report our discrepancies and probably return my unit to the manufacturer for testing.....a formality in the process i guess...</strong></p> <p><u>Person B:</u></p> <p><em>OMG - this a great find. …(information removed)…</em></p> <p><em>So I’m not nuts then, am I? I know it sounded nuts...but no, they are not good for APS patients. <br />My guess is, your wife will no longer being using a finger stick machine anywhere.</em></p> <p><u>Person A:</u></p> <p><strong>changes in management will be forthcoming....yes thank you.</strong></p> <p><u>Person B:</u></p> <p><em>Good to hear!!</em></p> <p><u>Person A:</u></p> <p><strong>http://www.devicelink.com/grabber.php3?URL=http://www.devicelink.com/mddi/archive/08/11/006.html <br />This starts out outlining lasik problems overview and then in the last paragraph lists a new head of department CDRH.....this should outline some of the regulatory flavor in DC.....quite complicated! There may be other better sources of info....i am just starting</strong></p> <p><strong>--------------------------</strong></p> <p><font size="3">Then Person A came back almost a month later and the following conversation occurred. This is still all in YouTube comments.</font> </p> <p>-------------------------</p> <p><u>Person A:</u></p> <p><strong>filing complaint with maude database fda </strong></p> <p><strong>it seems there are over 300 complaints over the last 2 years....I have looked at a few of them and I am amazed at the company responses......some statistical mumbo jumbo designed to quash the complaint....but in my mind not really a valid statistical treatment!! at least they don't give enough details for anyone to see what kind of statistics they are looking at.....anyway it is a mistake to look at these events in that way. If the fda lets them get away with this kind of response....well, they are simply not doing their job..</strong></p> <p><u>Person B:</u></p> <p><em>They didn't do anything with my problem. Roche buried it. APS patients are the minority. Until non APS patients starting having issues, they aren't going to do something...but the Detroit Office is trying to get these off the market. They are not accurate. <br />The companies don't give a damn...buyer beware. Hence why we have been screaming up and down there is a problem with them. The company may not tell you, but we will and if they search the net we are on the first page of hits. <br />The companies made their money on the client, they don't care. They excluded APS patients from their trials because they knew it wouldn't be accurate - cause it is a phospholipid that they use for a reagant - and would not get approved by the FDA. <br />Yet, your doctors are still letting your wife use these machines?</em></p> <p><em>BTW, you are still allowing your wife's doctors to use these machines?</em></p> <p><u>Person A:</u></p> <p><strong>yes, but not in isolation....several innacurate readings may b e better than one innacurate reading!! ie. hospital, doctor and home readings.... how's that for desperation? I believe that just about aLL these readings will fluctuate and show innacuracies as the level of lupus antigen changes. What concerns me is that if the statistical analysis put forth by the companies to justify their machines are fraudulent, then there would be a cause for definite action by the FDA....I am tempted to get a friend who is a statistician to call and talk to them a little....or has this been done?</strong></p> <p><u>Person B:</u></p> <p><em>Go for it. Yes, I do believe it is fraud.  <br />This information it is public record. I have called and asked them point blank if this information is not in their strips box, etc. I told them, their problem is they don't disclose it to patients unless they ask specifically. And that is where some deceptive practices also are. <br />And the mess after it is reported to them. It is sad. They try to blame the patient and the doctors for the mistakes...they have no intention of fixing their problems until a whole mess of people are seriously hurt or killed (and there have been people killed from the piss poor accuracy of these machines). Corporate greed.</em></p> <p><u>Person A:</u></p> <p><strong>http://www.clinchem.org/cgi/content/full/51/3/553 this link is to an article that calls into question the accuracy of most other methods of inr determination.....so even though warfarin is widely taken across the globe, we don't seem to have a handle on really accurate readings......this is critical for APS patients of course. .but don't assume that your hospital has accurate readings either!!!</strong></p> <p><u>Person B:</u></p> <p><span><em>My INRs are currently and always have been matching to the Factor X essay. It is checked each time there is a new batch of reagants. <br /> <br />So, no, I know my vein draws are accurate.</em></span></p> <p><span><u>Person A:</u> </span></p> <p><strong>http://www.clinchem.org/cgi/content/full/51/3/483 another article pointing out innacuracies of all methods,,,,So I am wondering how anyone has any confidence in any of these tests!!! I would have expected more scientific rigor in something this important to Medicine. <br />Boyd Clark, OD</strong></p> <p><strong>---------------------------------</strong></p> <p>And it ended there. I found it to be a very interesting read and hope you did too. Some of the links may not work, the companies have been burying the information and moving things around.</p> Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com1tag:blogger.com,1999:blog-7232228941129431680.post-89143869423392844412009-09-25T20:45:00.001-07:002009-09-25T20:45:17.363-07:00Updates coming….<p>It’s been a few months since I’ve updated this blog, but have no fear! I have two updates coming. One is from late May/early June and the other is more recent.</p> <p>I have to contact my source for the first story and see how they want it posted. </p> <p>Once I get the clarification, I will post the two updates. </p> <p>Check back soon. They will be worth it. </p> Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com0tag:blogger.com,1999:blog-7232228941129431680.post-16180538864174103392009-05-24T20:51:00.001-07:002009-05-24T20:51:41.810-07:00Hmmm…a Study About INR Machine Inaccuracies in APS Patients<p>First of all, has it been over a year since I’ve posted here?? I can’t believe that!!! I do have a few stories to add and will during the next week, but first I need to comment about this study that i ran across this evening.</p> <p><a title="http://clinicaltrials.gov/ct2/show/NCT00878137?cond=%22Antiphospholipid+Syndrome%22&rank=8" href="http://clinicaltrials.gov/ct2/show/NCT00878137?cond=%22Antiphospholipid+Syndrome%22&rank=8">http://clinicaltrials.gov/ct2/show/NCT00878137?cond=%22Antiphospholipid+Syndrome%22&rank=8</a></p> <p>Ok…a few things about this study. </p> <p>I do think it’s good that they are conducting a study and collecting data.  I don’t know that 2 months is long enough to collect "accurate” data, but what do I know. </p> <p>I don’t like a few things about it though…#1, the study is by “Invitation Only”…hmm, wonder why that is. And #2, the study is being run by ITC, who, if you will recall, had a recall of their machines in 2007. <a title="http://www.fdanews.com/newsletter/article?issueId=10981&articleId=100900" href="http://www.fdanews.com/newsletter/article?issueId=10981&articleId=100900">http://www.fdanews.com/newsletter/article?issueId=10981&articleId=100900</a></p> <p>So…why the Invite Only? And who’s doing the inviting?</p> <p>Are they getting a good mix of patients? Who knows…</p> <p>I guess we’ll have to wait for the results of the study to come out. </p> <p>Sounds like a bunch of butt covering to me. </p> <p>Also, then there’s going to be the issues of certain people who sing the praises of such machines, despite their obvious problems with APS patients (I mean, it’s even written in their machine inserts!). If this study should prove there to be no issues with these machines and APS patients, I am pretty sure that those people are going to take the study results as gospel and run with it!!</p> <p>In my opinion, if this study does “prove” these machines to be accurate, it’s still questionable and I’d still not trust it with MY life. I’ve done side by side comparisons, I’ve seen the differences between machine vs vein draws. I’m not going to be one of those “add .5 to the results on the 2nd Wednesday of the month and minus .3 on the 3rd Friday” type of people. 66% is not enough. </p> <p>I’ll be awaiting the results and will update when they come out. I’m curious to see what the findings are. </p> Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com1tag:blogger.com,1999:blog-7232228941129431680.post-4975285518728117332008-06-01T14:27:00.000-07:002008-06-02T17:54:06.028-07:00You "May" Want To Educate Instead of DebateDid a little more light reading. Have more to add as far as this topic goes.<br /><br />What keeps being brought up is this positive Lupus Anticoagulant. The companies who manufacture the top couple or few INR testing machines have a disclaimer in their package inserts about possible inaccuracies in readings with APS patients who have a positive LA. The links are on the side and I believe they say something about a false high reading. And I've already discussed the whole 1/3 or 33% issue.<br /><br />I found the following little blurb interesting:<br /><blockquote style="font-style: italic;"><span style="font-size:85%;">The first document is from Roche, and it does not say in all cases, and it does not even infer that it means all cases. This is a matter of interpretation. It does say:<br /><br />The presence of anti-phospholipid antibodies (APAs) such as Lupus antibodies<br />(LA) can potentially lead to prolonged clotting times, i.e., elevated INR values. A comparison to an APA-insensitive laboratory method is recommended if the presence of APAs is known or suspected.<br /><br />Yes it says a laboratory comparrison is needed when the presence of LA is is known or suspected. As LA activity is transient, that could be just once in three years of tests, as it has been with my tests.</span></blockquote>Do you, as an APS patient, know when your LA is positive? Does a little light go off somewhere to indicate that your LA is positive today and your INR test may be off? Are you SURE? 100% no questions SURE that your LA is positive on xx day?<br /><br /><span style="font-style: italic; font-weight: bold;">Would you be willing to bet your life on it?</span><br /><br />If you go by what that blurb above says then you are. So you're telling me you know the EXACT date or let's say time of year, when your LA is positive and are going to be expecting a false reading from your beloved machine.<br /><br />If you don't...how did you know that your INR was off in that ONE test in 3 years? Do you get a vein draw comparison EVERY time? No? Then you can't REALLY, honestly say that your INR was correct...can you?<br /><br />You're putting a lot of faith in a little machine that the manufacturers warn is not completely accurate for APS patients.<br /><br />What about those people who don't have a positive LA....what would then make their tests be off? Something to ponder.<br /><br />Next statement:<br /><span style="font-size:85%;"><span style="font-style: italic;"><blockquote>The exact wording is:<br /><br />Studies indicate interferences may occur in patients with antiphospholipid antibodies or antiphospholipid syndrome.<br /><br />- Sanfelippo MJ, Sennet J, McMahon EJ, 2000. Falsely elevated INRs in warfarin-treated patients with the lupus anticoagulant. WMJ. Jun; 99(3):62-4, 43.<br />- Rosborough TK, Shepherd MF, 2004. Unreliability of international normalized ratio for monitoring warfarin therapy in patients with lupus anticoagulant. Pharmacotherapy Jul; 24(7):838-42.<br />- Perry SL, Samsa GP, Ortel TL, 2005. Point-of-care testing of the international normalized ratio in patients with antiphospholipid antibodies.<br />Thromb Haemost. Dec; 94(6):1196-202.<br /><br />The important word there is' may'. If I said the world MAY end tomorrow, would you think it was going to as a matter of fact? No, you would probably assume that anything MAY happen but you doubt if the world will end. </blockquote></span></span>I'm going to focus on the last paragraph, but didn't want to take it out of context. The important word is "may". That I agree with. But...and you knew a but was coming...I have this to say. If I knew the would "may" end, I would at least be prepared for it to end. I'd spend the day with loved ones, eat my favorite foods, get really drunk, try something I'd always wanted to do but never did...etc. If I knew that 33% of the time my car may not start, I'd be sure I had roadside just in case. I'd want to be prepared. If I knew that the school my children were supposed to go to "may" have asbestos, I would probably find a new school.<br /><br />People who buy these machines are going by recommendations from the medical community (who are probably getting some sort of kickbacks), from organizations (who are also probably getting kickbacks) and individuals who use the machines (and I'm not convinced some of them aren't ALSO getting kickbacks). They may or may not be buying them blindly, without knowing that 33% of the time they may have an inaccurate reading with a positive LA. They might not have done the research necessary to get the full picture. Not just the rosy painting that the many people who successfully use these machines paint for them...how wonderful it is to have the freedom to check your INR from home and not have to have the inconvenience of going to the lab and waiting for the vein draw. They may not know that these machines are known to have inaccuracies in some APS patients.<br /><br />On to the third statement:<br /><blockquote style="font-style: italic;"><span style="font-size:85%;">I know I have, and many others who have the sence and knowledge to understand the possiblity of a false high then there can be no problem. As for those who cannot use the machine at all, Roche (the only manufacturer I mention) will offer a full money back warranty if it is agreed prior to purchase. You can't be fairer than that for those few who cannot use the machine at all.</span></blockquote>Why can there not be a problem? Just because you know there can be a false high? Do you know WHEN the false high is coming? Why make it a guessing game. For the convenience?<br /><br />Also...be SURE to ask if the company you're getting your machine from WILL in FACT take it back and refund your money. They may only have a 90 day return policy and say that you find your false readings on day 127. Then you may be stuck with a worthless machine.<br /><br />My goal is to educate. Know the facts before you buy. Don't buy into the hype. What works for others may not work for you.<br /><br />I'll leave you with a different kind of quote. From a different source, obviously. (not my words)<br /><span style="font-style: italic;"><blockquote>I had the same technical data, my hemo's office gave it to me. I think one of the reasons that he switched to that brand from ProTime because it's the machine with the highest accuracy rate (2/3) for APS patients. To me, the bottom line is that even if it works flawlessly for me, or anyone else with APS, it's still wrong in 1/3 of APS patients, and that's just not a good enough success rate. As I said to my hemo, 2/3 is only a good ratio if you're not in the 1/3 that's left over!</blockquote></span>And one more...(not my words)<br /><span style="font-style: italic;"><blockquote>Finger sticks for APS do not work. I have had too many wrong readings that could have put me at risk for a bleed or a clot. I finally got educated and found that the self test machines, and finger sticks are not accurate MOST of the time. It is not worth risking my health because a lab or doctor refuses to monitor my INR the CORRECT way. If they don't want to do my care properly, I would transfer my business elsewhere, no if, ands, or buts!</blockquote></span>If you didn't know anything about these machines but how wonderful they are and how convenient they are, then you wouldn't know the risk you may face of false readings. You wouldn't know your life may be at risk because if the reading is a false low and your true INR is much higher then you face a bleed. On the flipside, if your reading is a false high and your true INR is low then you could be facing a clot...and it may not be a DVT, but it may be a PE or stroke that may result in your death.<span style="font-style: italic;"><br /></span>Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com1tag:blogger.com,1999:blog-7232228941129431680.post-81441907641165161422008-05-30T16:47:00.000-07:002008-06-02T17:54:06.029-07:00Accurate 66% of the time?Normally I wouldn't copy and paste like this, but I've been doing a little "light reading" lately and what I'm reading is absolutely absurd!!<br /><br />Let's take example #1 for instance:<br /><blockquote style="font-style: italic;"><span style="font-size:85%;">You are welcome to your opinion about the accuracy of the machines but I have not seen any study or data that indicates it is less accurate than a lab test? I think it is just the opposite and more accurate than many lab tests. For the lab test you have the draw, the handling, the storage, the transportation, a time lag that can be up to several days before the test is really done and all of these can contribute to a wrong result from the test.<br />Different tests (reagents at least) are used in different labs. With the machine, the blood is always fresh, everything is automatic and there is almost no chance for an inaccurate test. In addition you don't get collapsed veins or someone jabbing you and moving the needle around trying to find a vein. Add in the ease of not needing to even leave the room, getting the results in minutes, available at any time day or night and even on holidays and I can understand why someone might want to use a machine. The machines in Doctors offices and some labs are the same machine used at home.<br />BTW, I would suggest anyone who gets a strange reading, high or low, from a lab (or a machine) should have the test repeated as labs do make mistakes and we need to be certain ours are right before we make any drastic changes. This is much easier to do if you have a machine.</span></blockquote>Now if we break this down a bit and look at the facts. The companies that make these home testing machines put disclaimers in their package inserts about APS patients and possible inaccuracies. No data? There's data from the company who make the machines.<br /><br />True that when the blood is tested with the machine it's fresh. There are no handling issues and yeah, it's a lot more convenient. However...is convenience worth the risks that possibly having a WRONG reading will cause?<br /><br />What happens when an APS patient's INR is too high? They could have a bleed...which, although may not be life threatening, could be very dangerous. What happens when an INR patient's INR is too low? They could have a clot. Maybe it will be "just" a DVT....hmm, but couldn't a DVT lead to a PE...and couldn't the clot be a stroke instead of a DVT?<br /><br />So convenience basically is worth the risks of an inaccurate test and a possible bleed/clot?<br /><br />I guess it is for some people.<br /><br />Another example to consider:<br /><blockquote style="font-style: italic;"><span style="font-size:85%;">I will say that I was told by others with APS that it is dangerous for us to use. I saw the success that so many in the UK are having, so I asked my hemo (after I found a good one that speaks frankly with me). He said that if you have the intelligence to calibrate the machine and you can learn through your doctors guidance to understand how to make simple adjustments and know when there is an emergency... He believes the machines are very helpful. He said that given the patient more control over his/her healthcare is beneficial in many ways. When I asked specifically about the things I read about APS patients, he said it was "nosense"<br />and maybe a "scare tactic of someone that likes drama" (His words, not mine). He explained that if you get a false high reading on the home machine, you are going to get a false high at the lab.</span></blockquote>So...if a patient has the intelligence to calibrate the machine then they should be all set? Well, with simple adjustments and such. So what would be the reason that an office or clinic's machine would give a false reading? Perhaps the nurse or whoever in the medical field working in the office/clinic wasn't "intelligent" enough to calibrate and adjust the machine so the reading wouldn't be inaccurate. I'd certainly trust a nurse more than myself...and don't we have a story about someone who's CLINIC reading was off with the finger stick machine?<br /><br />And remember we're not only talking about false HIGH readings, but also false LOW readings. Personally, the low ones would scare me more than a too high reading.<br /><br />On to my third example:<br /><blockquote style="font-style: italic;"><span style="font-size:85%;">I would never recomend one of these machines to a person who was permanantly positive for LA as the machine would just not worg for 33% of them (the other 66.6% would still be OK, but the constant worry of a possibility of a false high would be too much to bear. For the vast masjority of patients these machines are helping them in their daily control of the disease and helping them keep complete records to share with others on what effects their day to day INR levels.</span></blockquote>APS antibodies tend to wax and wane. Basically, you may be positive for the LA one month and not be the next...or maybe you've have 15 tests and been positive for it once...this does happen in APS patients.<br /><br />33% with a positive LA may have inaccurate readings. Let's break this down a bit. If you have a positive LA and you get your INR drawn 90 times with a finger stick machine, 30 of those have the potential of being inaccurate. Do you know when those 30 times are going to happen? Can you guess or determine when by how you're feeling on any given day? Should you have to guess at all?<br /><br />Would you buy a computer that worked 66% of the time? How about a car? Would you want your electricity or heat to only work 66% of the time?<br /><br />Would you pick a doctor who misdiagnosed people 33% of the time?<br /><br />I don't know...to me, the proof is in black and white. The data is in black and white. Maybe there's not an official "study" but there is literature out there.<br /><br />Educate yourself before you buy into this INR machine business. Convenience isn't always the "best" way.<br /><br />Let's also consider this: the word "may" is used a lot in these types of posts. Basically, it's used to cover the poster's ass. And yes I know, I use it too...but think about it:<br /><ul><li>Stool softeners "may" cause diarrhea.</li><li>Condoms "may" stop the transmission of STDs.<br /></li></ul>Don't take MY word for it...after all, I'm just someone who's using "scare tactics" to stir up "drama"....when actually, I'm only doing that 66% of the time. *insert eyeroll here*Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com4tag:blogger.com,1999:blog-7232228941129431680.post-57239011749640716022008-04-21T18:28:00.000-07:002008-06-02T18:00:22.293-07:00Ali04's TestimonyAhh....another machine not working.<br /><br /><span style="font-style: italic;">i also have aps, history of one stroke, with recurrant clots while on coumadin. </span><br /><span style="font-style: italic;"> i had the protime, and when checked against the lab, was found to be faulty. </span><br /><span style="font-style: italic;"> i was told by the company that it may be inaccurate for people with the lupus anticoagulant. </span><br /><span style="font-style: italic;"> be careful, and once in a while check it against the lab. the differences i had were alarming. </span><br /><span style="font-style: italic;"> the company apologized, said i shouldnt use it, and refunded my money. that was in 01.<br /><br /></span><span style="font-size:78%;">Originally posted on Healthboards:<br /><a href="http://www.healthboards.com/boards/archive/index.php/t-352980.html">http://www.healthboards.com/boards/archive/index.php/t-352980.html</a></span><span style="font-style: italic;"><br /></span>Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com1tag:blogger.com,1999:blog-7232228941129431680.post-70761779469915309622008-02-25T13:54:00.000-08:002008-06-02T17:54:06.030-07:00Education is the KEYEvery few months or so the topic of home INR machines is brought up and as of late, debated, on APS support forums and e-lists.<br /><br />It appears as though certain groups are pushing people to get the machines and even promoting the purchase of the machines (as if they were getting a kick back from them?). And then there are other groups who are adamantly against the machines.<br /><br />These machines have put into their literature that there are "limitations" when it comes to APS patients. They mention those who have a positive Lupus Anticoagulant, however, listed here we have a personal story from someone who has a negative LA and actually has Seronegative APS or SNAPS and she had problems with her home machine.<br /><br />Did you know that there can be other factors that can also affect the readings? Anemia is one thing, and also Lovenox/Heparin use within 24 hours of the reading can cause it to be off.<br /><br />If you needed a carseat for your child and there were only two to choose from…would you buy the one that had listed certain "limitations" or would you go for the one that was deemed "safe"? Maybe not a good comparison, but the warnings are in black and white. Who can question that?<br /><br />If you get your INR from your home machine and have to "add or subtract a point" because you KNOW it's off…what does that tell you?? What if it's off by 2 or 3 points and you only added 1? So then a 2.2 reading…+ 1 pt would be 3.2…but it's off 2, so your TRUE INR is actually 1.2??? Do you know what can happen to some people when their INR drops that low?? Clots…Strokes…PE's…<br /><br />Is the convenience of having the machine at home worth risking your life over?<br /><br />I am urging you to educate yourself. Call the companies, ask the questions. If your doctor is pushing this machine, do they get money for each machine sold? Same with an organization that may be pushing it…are THEY getting money for each machine sold? Talk to people who use the machines. Ask them how often they do comparisons with a vein draw. Read the stories of people who have had problems. 1 in 10 is one too many if you ask me.<br /><br />Educate yourself. Make an educated decision, not a knee jerk, convenience decision. The "limitations" are in black and white. If you have APS…YOU are the limitation.<br /><br />This is also referring to the finger stick machines at the clinics or dr offices. One of the stories was from a dr's machine and not a home machine.<br /><br />It's your life, your decision. Is the convenience of not going to the clinic worth your health and possibly your life? How convenient will it be for yourself, your family, friends and loved ones if you're dead?Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com1tag:blogger.com,1999:blog-7232228941129431680.post-38129923663199266292008-02-24T14:16:00.000-08:002008-06-02T18:00:22.294-07:00Lyn's Experience<span style="font-style: italic;">These are excerpts taken from a thread in the APS Friends and Support forum located at www.apsforum.com. </span><br /><br />How about the finger stick in the hospital lab? I like it because I know my INR right away. But if the elbow stick is more accurate.... The only time I had both a finger stick and the elbow stick, the numbers were the same.<br /><br />I had the chance to get a little evidence on my own. I had a blood draw from the doctor's, and asked them to do a pt/inr, then I went straight to the hospital where I have a standing order. and got a finger stick. the finger stick was 1.9, the venopuncture was 2.3. Venopuncture from now on.<br /><br />I'm going to tell the people at my hospital that APS people shouldn't get fingersticks. I think we all should tell our doctors, phlebotomists, vampire people, etc. that venous is the only way for us APS folks. They don't necessarily read the literature, and APS is such a new diagnosis that they haven't learned this in school, and it hasen't hit the continuing medical education courses. So we 'special ones' surround us with people who do know that. lrb<br /><br /><a href="http://www.apsforum.com/forum25/10469.html"><span style="font-size:85%;"><span style="font-style: italic;">http://www.apsforum.com/forum25/10469.html</span></span></a><span style="font-size:85%;"><br /><span style="font-style: italic;">(registration required)</span></span>Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com1tag:blogger.com,1999:blog-7232228941129431680.post-81871692481743716782008-02-20T14:10:00.000-08:002008-06-02T18:00:22.295-07:00Bec's Experience with INRatio.I gave the finger prick test a try, too. Came back as 4.1, so they said "great, let's leave your dosage alone." I told the dr that I was not confident in that result because my body was telling me that my INR was below 3. I asked to be sent to the hospital for a stat venous draw. They humored me and I had the stat draw within 10 min. It came back 2.3. No more finger stick for me! The dr called the company (INRatio) and the company said it wasn't accurate for a lot of people with APS. Now, the dr is trying to find out which of her patients have APS, so she can check all of them as well.<br /><div><br />I go to Labcorp for the venous draws, and I mentioned how the finger stick was so inaccurate. The phlebotomist said she has several people who come in for venous draws because it is inaccurate for them as well; she said that is one of the reasons why Labcorp has not switched over.<br /><br />I speak from personal experience, and the INRatio machine is not accurate for people with APS. After the huge discrepancy with my result, my dr called the company and the company admitted that it is not accurate for people with APS. If you do a search on their website (hemesense.com), you can find the warning.<br /><a href="http://www.apsforum.com/forum25/10469.html"><br /><span style="font-size:85%;"><span style="font-style: italic;">http://www.apsforum.com/forum25/10469.html</span></span></a><span style="font-size:85%;"><br /><span style="font-style: italic;">(registration required)</span></span><br /></div>Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com2tag:blogger.com,1999:blog-7232228941129431680.post-4516701620289457742007-09-11T08:49:00.000-07:002008-06-02T18:00:22.296-07:00Jeanette's ExperienceI recently purchased a self testing device called CoaguChek XS. It is<br />manufactured by Roche and I purchased it via Tapestry Medical in Livermore,<br />California.<br /><br />I was so excited to finally convince my doctor to give me a prescription for<br />the device. Even though I had to pay for it myself (it cost $2300 and my<br />health plan would not pay for it), I thought it would help me to regulate my<br />INR.<br /><br />My doctor suggested that I continue getting vein draws at the lab while I'm<br />also testing at home for a while to verify the reliability of the machine.<br />The first time I tested last week the difference between the lab draw and<br />the self test (conducted within 30 minutes of each other) was only 0.3 so I<br />was highly encouraged.<br /><br />Unfortunately, a week later and the second time I tested, the CoguChek said<br />my INR was 4.3 but the vein draw said only 3.5. For me this is a<br />significant difference because at 4.3 my meds are reduced but at 3.5 I stay<br />at the same dosages until the next test.<br /><br />I called Roche and expressed my concerns about the reliabilty of the<br />machine. They told me that at higher INRs (above 4.0) the machine becomes<br />less reliable. They also told me that the machine doesn't work very well<br />for people with Antiphospholipid Antibodies because these same antibodies<br />are on the test strips! She said that especially when someone with APS is<br />having a flare up the machine may not work well due to the high level of<br />antibodies in the blood.<br /><br />I feel like I wasted $2300 and I think the company should have told me that<br />the machine doesn't work well for people with APS. I'm frustrated with<br />myself for making this purchase without doing more research.<br /><br />I'm sharing this with all of you in hopes that I'll be able to prevent<br />someone else from wasting their hard-earned money.<br /><br />By the way, I'm asking the company for a full refund and if they refuse I am<br />going to file a claim in Small Claims Court.<br /><br />- Jeanette in California<br /><br />Originally posted on APLSUK (registration required) <a href="http://health.groups.yahoo.com/group/APLSUK/message/49519">http://health.groups.yahoo.com/group/APLSUK/message/49519</a>Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com1tag:blogger.com,1999:blog-7232228941129431680.post-42740836416363692992007-09-11T08:38:00.000-07:002010-01-16T10:01:37.008-08:00Todd Had a TIA Using a Finger Stick Machine in his Lab at the Hospital<span style="color: rgb(0, 0, 0);">Written by Todd's wife, Heidi in the </span><a style="color: rgb(0, 0, 0);" href="http://www.apsforum.com/">APS Friends & Support Forum</a><br /><br /><span style="color: rgb(0, 0, 0);">Or for those people who are thinking about getting one...</span><br /><br /><span style="color: rgb(0, 0, 0);"> PERFECT EXAMPLE of how they just DO NOT work with APS patients....</span><br /><br /><span style="color: rgb(0, 0, 0);"> Todd's been getting LAB INR MACHINE draws for months. We DID comparisons...a few in a row...all was fine...they matched, I was ok...a bit skeptical, but ok with them. </span><br /><br /><span style="color: rgb(0, 0, 0);"> Well, Todd hasn't been feeling well. </span><img style="color: rgb(0, 0, 0);" src="http://www.apsforum.com/themes/shades/fever.gif" alt=":fever:" /><span style="color: rgb(0, 0, 0);"> for a week or so now... Went to get an INR drawn...usual way, finger stick in the lab. INR came back 3.9</span><br /><br /><span style="color: rgb(0, 0, 0);"> A little high for him (his range is 3-3.5) but still ok...didn't explain why he felt like dog doo...but ok, stranger things have happened, this is APS fgs. </span><img style="color: rgb(0, 0, 0);" src="http://www.apsforum.com/themes/shades/00002.gif" alt=":dunno:" /><br /><br /><span style="color: rgb(0, 0, 0);"> Anyhow...he starts getting right side numbness WITH the Migraine that he had. </span><img style="color: rgb(0, 0, 0);" src="http://www.apsforum.com/themes/shades/headache.gif" alt=":head:" /><br /><br /><span style="color: rgb(0, 0, 0);"> Goes into the ER... </span><img style="color: rgb(0, 0, 0);" src="http://www.apsforum.com/themes/shades/ambulance.gif" alt=":ambulance:" /><br /><br /><span style="color: rgb(0, 0, 0);"> Well folks...they did a VEIN draw...Guess what his INR was???? 1.5!!!! </span><img style="color: rgb(0, 0, 0);" src="http://www.apsforum.com/themes/shades/hissyfit.gif" alt=":hissy:" /><br /><br /><span style="color: rgb(0, 0, 0);"> ONE POINT FIVE????? omg </span><img style="color: rgb(0, 0, 0);" src="http://www.apsforum.com/themes/shades/duh.gif" alt=":duh:" /><br /><br /><span style="color: rgb(0, 0, 0);"> That is a HUGE difference...HUGE!!!!! </span><img style="color: rgb(0, 0, 0);" src="http://www.apsforum.com/themes/shades/woah.gif" alt=":woah:" /><br /><br /><b style="color: rgb(0, 0, 0);">So he had a TIA everyone. <img src="http://www.apsforum.com/themes/shades/tired.gif" alt=":exhaust:" /></b><br /><br /><span style="color: rgb(0, 0, 0);"> I'll tell you this. I am going to be on the phone </span><img style="color: rgb(0, 0, 0);" src="http://www.apsforum.com/themes/shades/i.p.emphone.gif" alt=":phone:" /><span style="color: rgb(0, 0, 0);"> tomorrow MAKING SURE that was his LAST INR draw with the finger stick. it's back to good old fashioned vein draws for Mr. Todd. </span><img style="color: rgb(0, 0, 0);" src="http://www.apsforum.com/themes/shades/12.gif" alt=":mad:" /><br /><br /><span style="color: rgb(0, 0, 0);"> He hasn't had a TIA since APRIL!!! </span><img style="color: rgb(0, 0, 0);" src="http://www.apsforum.com/themes/shades/zbanghead.gif" alt=":banghead:" /><span style="color: rgb(0, 0, 0);"> </span><br /><span style="color: rgb(0, 0, 0);font-size:130%;" ><br /><b>So, please anyone...tell me again WHY you want a machine? </b></span><br /><br /><span style="color: rgb(0, 0, 0);"> Here's a thread to read also... </span><a style="color: rgb(0, 0, 0);" href="http://www.apsforum.com/forum25/6543.html" target="_blank">http://www.apsforum.com/forum25/6543.html</a><br /><span style="color: rgb(0, 0, 0);">(registration required)</span><br /><br /><span style="color: rgb(0, 0, 0);"> You're putting your life into a machine that is KNOWN to be wrong with APS patients...think TWICE...THREE times...FOUR times and Just say NO! </span><img style="color: rgb(0, 0, 0);" src="http://www.apsforum.com/themes/shades/thumbdown.gif" alt=":thumbsdown:" /><img style="color: rgb(0, 0, 0);" src="http://www.apsforum.com/themes/shades/thumbdown.gif" alt=":thumbsdown:" /><img style="color: rgb(0, 0, 0);" src="http://www.apsforum.com/themes/shades/thumbdown.gif" alt=":thumbsdown:" /><br /><br /><span style="color: rgb(0, 0, 0);">Original Post: </span><a style="color: rgb(0, 0, 0);" href="http://www.apsforum.com/forum25/6943.html">http://www.apsforum.com/forum25/6943.html</a><span style="color: rgb(0, 0, 0);"> (registration required)<br /><br />And in his own words:<br /><br /></span><span style="color: rgb(0, 0, 0);font-family:arial black;" ><span style="font-size:100%;">Here is the Jist of the ordeal I went through. I was feeling tingiling and numbness on my right side and a migraine the day before i went into the clinic just so you know. I went to have my blood drawn at the aticoagulation clinic yesterday. And my inr was a 3.6 from a finger prick.<img src="http://www.apsforum.com/themes/shades/thumbdown.gif" alt=":thumbsdown:" /><img src="http://www.apsforum.com/themes/shades/thumbdown.gif" alt=":thumbsdown:" /><img src="http://www.apsforum.com/themes/shades/thumbdown.gif" alt=":thumbsdown:" /><img src="http://www.apsforum.com/themes/shades/thumbdown.gif" alt=":thumbsdown:" /> Than I talked to my hematoligists nurse practioner right after that and she couldn't figure out what it was from. She thought it could have been from the migraine. So I left there and went to another hospital because if Heidi were to come to see me I didn't want her to have to come down to that hospital because you have to drive down dark roads to get to the hospital. So I went to the one close to the house. They got me in. Did and INR draw and it was 1.5. Thats a big change from 3.6 don't ya think. They gave me compazine and 3 tylenol for the numbneess and tingiling and migraine and it went away. And they did a head ct and ruled a TIA. They didn't want me to leave but I was able to finagle my way out by saying I have lovenox at home. So to people who want to get Inr machines for the house. Don't get them look what it did to me.<img src="http://www.apsforum.com/themes/shades/thumbdown.gif" alt=":thumbsdown:" /><img src="http://www.apsforum.com/themes/shades/thumbdown.gif" alt=":thumbsdown:" /><img src="http://www.apsforum.com/themes/shades/thumbdown.gif" alt=":thumbsdown:" /><img src="http://www.apsforum.com/themes/shades/thumbdown.gif" alt=":thumbsdown:" /><img src="http://www.apsforum.com/themes/shades/thumbdown.gif" alt=":thumbsdown:" /><img src="http://www.apsforum.com/themes/shades/thumbdown.gif" alt=":thumbsdown:" /><img src="http://www.apsforum.com/themes/shades/thumbdown.gif" alt=":thumbsdown:" /><img src="http://www.apsforum.com/themes/shades/thumbdown.gif" alt=":thumbsdown:" /></span></span>Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com5tag:blogger.com,1999:blog-7232228941129431680.post-65441456682808050822007-09-11T08:33:00.000-07:002010-01-16T10:02:47.662-08:00Tina's Experience with Home INR Machines.<span style="font-weight: bold;"></span><!--area Type="subhead" face="Verdana,Arial,Helvetica,sans-serif" size="3" color="000000" style="3"--><!--/area Type="subhead"--> <!--area Type="main" style="0;font-family:Verdana,Arial,Helvetica,sans-serif;font-size:85%;color:000000;"--> <span style="color: rgb(0, 0, 0);font-family:Verdana,Arial,Helvetica,sans-serif;font-size:85%;" ><div> <p class="MsoNormal" style="margin: 0pt; color: rgb(102, 0, 0);"><i><span style="color: rgb(153, 0, 51);font-family:Georgia;" ><span style="font-size:100%;">Brand of Machine:</span></span></i><span style="font-size:100%;"><i><span style="font-family:Georgia;"><span style="color: rgb(255, 204, 204);"> </span>Roche CoaguChek S™<br /></span></i><i><span style="color: rgb(153, 0, 51);font-family:Georgia;" >Diagnosis:</span></i></span><span style="font-size:100%;"><i><span style="font-family:Georgia;"><span style="color: rgb(255, 204, 204);"> </span>SNAPS<br /></span></i><i><span style="color: rgb(153, 0, 51);font-family:Georgia;" >Experience:</span></i></span><span style="font-size:100%;"><i><span style="font-family:Georgia;"> After much convincing from other APS patients to get this particular machine, I got it. My insurance company refused to pay for it – and since I was told it was basically the next best thing to sliced bread – I paid for it out of my own money….close to $2000USD.<br /><br />I did many comparisons with the machine before I and my doctor would accept the machine’s numbers. Things were working fine. The periodic comparisons were fine. Almost a year went by with no real problems or at least nothing that caught my attention. However, it was during that time, others who had problems with this machine came to me and gave me in-house documents regarding this particular machine. I was never told that this machine has a standard of deviation of 20% +/-. I also found out this particular machine has problems with APS patients.<br /><br />All the sudden I started having problems. My INR was not matching my symptoms. Well, both my doctor and I assumed my machine was reading right and we would correct the dose. We played this game for a few months. I suspected a problem but would check family members who aren’t on Coumadin® and their INR read right. The controls were fine. It wasn’t until I had another full blown TIA that I realized something was seriously wrong - only this time my machine read 7.0. I checked it again, 7.8. I thought this couldn’t be right; my INR was 2.6 the day before. I checked it again, 7.2. Ran all the controls again – both liquid and electronic. Those all read fine. Of course, I got freaked and thought this was a bleed. Went to the ER and my INR was really 4.8. Still having the TIA but that machine was off, really off. I called the company. They said their machine was fine if the controls were fine.<br /><br />We thought that was a fluke. I checked my INR in a few days after an adjustment down. I got a reading of 7.8. I know that wasn’t right. Hospital said it was 3.5. I ordered a new box of strips, more liquid controls and started comparing batch to batch to INR. The batches were matching up but none of it to the lab. The lab readings were how I was feeling. It got me thinking how long was this machine off a few months ago when we assumed it was right. I was very lucky I didn’t have a full blown stroke because of the machine. It was at that point I stopped using the machine. I just couldn’t trust it any longer.<br /><br />After about 6 months, I got my INR back on track by going to the lab once a week. I thought I would spend the money and get a new box of strips since the others were expired and see if this expensive machine would work for me again. I started again doing comparisons. The machine was still off. I am done using it. I will deal with the hassle of going to the lab. At least I know those INR’s are correct. I have smashed the machine into a million peices and really disgusted at what a waste of money it was. I could have donated that money to the APS Foundation of America, Inc or something. Next time I will do my own research before believing word of mouth, promotion from a group and taking everyone’s experiences into consideration. I encourage you to do the same and make an </span></i><i><span style="color: rgb(153, 0, 51);font-family:Georgia;" >informed decision</span></i></span><i><span style="font-family:Georgia;"><span style="font-size:100%;">. This is your life and it could be your death that these machines could cause.<br /><br />Since Roche doesn't like their information on line. I will put it on line for them - at least I can say they were willing to provide the information that was asked for them. (Thanks!) These are the information sheets from the company talking about their standard of deviation and that they warn the APS patients of use of the machine. <o:p></o:p></span></span></i></p> <p class="MsoNormal" style="margin: 0pt; color: rgb(102, 0, 0);"><i><span style="font-family:Georgia;"><span style="font-size:100%;"> <o:p></o:p></span></span></i></p> <p class="MsoNormal" style="margin: 0pt; color: rgb(102, 0, 0);"><i><span style="font-family:Georgia;"><span style="font-size:100%;">ProTime, the makers of the professional model Hemachron, Jr. which also has problems reading accurate with APS patients. I know the issues with the Hemachron, Jr were reported to the company and the FDA as an adverse event.<o:p></o:p></span></span></i></p> <p class="MsoNormal" style="margin: 0pt; color: rgb(102, 0, 0);"><i><span style="font-family:Georgia;"><span style="font-size:100%;"> <o:p></o:p></span></span></i></p> <p class="MsoNormal" style="margin: 0pt; color: rgb(102, 0, 0);"><span style="font-size:100%;"><i><span style="font-family:Georgia;">The rest of the companies have their information readily accessible. Thank you for keeping it real and not hiding the information!<br /><br />Happy <st1:city st="on"><st1:place st="on">Reading</st1:place></st1:city>. </span></i><i><span style="color: rgb(153, 0, 51);font-family:Georgia;" >Use these machines in general at your own risk.</span></i><i><span style="font-family:Georgia;"><span style="color: rgb(255, 204, 204);"> </span>If you don't have autoimmune problems like APS, these machines may be ok for you but be fully aware there are problems with these machines and don't let anyone tell you there isn't a problem. I have collected enough factually supporting information to support my stance...add in my personal experience and others.....well. <o:p></o:p></span></i></span></p> <p class="MsoNormal" style="margin: 0pt; color: rgb(102, 0, 0);"><i><span style="font-family:Georgia;"><span style="font-size:100%;"> <o:p></o:p></span></span></i></p> <p class="MsoNormal" style="margin: 0pt; color: rgb(102, 0, 0);"><span style="font-size:100%;"><i><span style="font-family:Georgia;">On a side note, I have been hearing good things about the CoaguChek XS, well from 2 people - that have APS but their disclaimer is quite clear. </span></i><i><span style="color: rgb(153, 0, 51);font-family:Georgia;" ><span style="color: rgb(255, 204, 204);">Buyer Beware!</span><br /></span></i></span></p><p class="MsoNormal" style="margin: 0pt; color: rgb(102, 0, 0);"><br /><span style="font-size:100%;"><i><span style="color: rgb(153, 0, 51);font-family:Georgia;" ></span></i></span></p><p class="MsoNormal" style="margin: 0pt;"><span style="font-size:100%;"><i style="color: rgb(102, 0, 0);"><span style="color: rgb(153, 0, 51);font-family:Georgia;" ><a href="http://eyzrbrn.tripod.com/id20.html">Click here to see this story on Tina's Website</a></span></i><b><i><span style="color: rgb(153, 0, 51);font-family:Georgia;" ><br /></span></i></b></span></p></div></span>Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com2tag:blogger.com,1999:blog-7232228941129431680.post-49267967467689147262007-09-11T08:25:00.000-07:002008-06-02T17:54:06.030-07:00ReasonsI started this blog to help share the stories of patients who were talked into buying and using a home INR machine by either other APS patients or by their medical doctors. These machines have disclaimers in their paperwork that says they are NOT compatible with APS patients. Antiphospholipids are sometimes used as a reactant. YES, antiphospholipids!<br /><br />If you have had a negative (or positive) experience with a home INR testing machine and you'd like to share your story, please email me at <span style="font-weight: bold;">apsno2homeinr@gmail.com</span> and tell me your story. I will post it here to share with others.<br /><br />Thanks for reading.Finger Stick Machine Educationhttp://www.blogger.com/profile/16601438787866118664noreply@blogger.com1