Antiphospholipid Antibody Syndrome (APS) - SAY NO to Home INR and Finger Stick Machines!!

Source: http://www.dailystrength.org/c/Deep_Vein_Thrombosis_DVT/forum/8947591-digital-inr-meters

Notice, this is NOT an APS forum, group, what have you. This is something that showed up in my Google alerts recently.

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.

Scary stuff…

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.

Two back to back readings. Both different. And to me, the moral would be…don’t get tested on the machines. Period.

Same person posting…a couple days later:

…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....

Again…two different readings, two different machines and almost a 3 point difference! That’s HUGE!

The person posted back the results from his vein draw…wait for it…wait for it:

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!!

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.

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?

Wow. Just wow.

I will be keeping my eye on this site/thread because it’s new and still going on.

Just food for thought. 

Source: http://www.dailystrength.org/c/Deep_Vein_Thrombosis_DVT/forum/8947591-digital-inr-meters

Ooh, I guess I pissed someone off!

Funny that this blog has been here since 2007. Look at the archives. 2007 was the first post.

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.

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. Thank you!

I got a few comments I’d like to respond to.

One person asked to have their name removed. Since they didn’t leave their name, I don’t know WHICH 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.

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.

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.

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.

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.

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.

I also have a challenge for those who SWEAR by these machines.

Show me PROOF that they are accurate.

Give me the black and white.

Bet you can’t.

Leave it in a comment.

I dare you to.

I’d like to share my own APS story with you.

My mother had APS.

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.

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.

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!

Right…?

WRONG!!

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.

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.

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.

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”.

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.

It was probably only minutes, but seemed like time stood still.

The doctor who saw my mother earlier said that they lost her and that he was sorry, but they did everything they could.

My mother died from a Pulmonary Embolism from a DVT in her calf on September 2, 2007. She was 58 years old.

When we got her medical records after her death her INR from the blood draw in the hospital was a 0.9.

It was a 3.1 from her trusted machine just earlier that afternoon.

The strips were new and properly stored, the machine was clean, and the INR finger stick machine reading was WRONG.

And my mother died.

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.

And it was still WRONG. And my mother died.

So now you know why this is important to me and why I am educating people.

Convenience is not worth a life. The machines are wrong for APS patients. Plain and simple.

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?

My mother didn’t have to die.

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?

Possibly YOUR life? Think about it.

Links to back up the claims. Proof in black and white. What more do you need?

Happy reading.

*INR Monitoring in Patients with Antiphospholipid Antibodies with Finger Stick INR Machines.
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.  

Antiphospholipid Antibody Syndrome (APS) - NO to Home INR Machines!!
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!  

CoagCheck Systems
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.  

CoaguChek & CoaguChek S Strip Insert
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.  

CoaguChek XS System - Patient Experience
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."  

CoaguChekXS Strip Insert
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.  

Devices for ambulatory and home monitoring of blood pressure, lipids, coagulation, and weight management, part 2
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.  

Factors That Influence INR system Comparisons
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.  

For those inquiring about HOME INR machines...
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!"  

Hemochron Jr. Package Insert
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.  

Home INR Machines and Antiphospholipid Antibodies
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  

i-STAT® PT/INR test
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.

INR Self Testing
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.  

INRatio by Hemosense
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. 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.  
INRatio Monitor and Interfering Substances
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.  

MAUDE Adverse Event Report
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.  

MAUDE Adverse Event Report
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.  

MAUDE Adverse Event Report
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.  

My Experience with Finger Stick (Home) INR Machines
Patient's story on her use of a Home INR Machine and supporting company information.  

Patient Variables in PT/INR Testing with INRatio
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.  

Point-of-care testing of the international normalized ratio in patients with antiphospholipid antibodies.
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.  

Protime Machine
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.  

ProTime Microcoagulation System Package Insert
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.  

Questions and Answers: For Use with CoaguChek® Test Strip Urgent Medical Device Correction (UMDC) 06-266 and Urgent Medical Device Recall (UMDR) 06-267
11/16/06: CoaguChekS now has a 30% +/- acceptable standard of deviation.  

Thoratec Receives FDA Warning Letter, Plans Recall (ProTime)
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.  

Validity of Criteria Used to Evaluate Fingerstick Devices That Assess International Normalized Ratio
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.

These are all from the APSFA Fan page on Facebook. One of their members listed an article posted on Associated Content and that started quite a discussion!

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.

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.

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.

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!

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.

Ran across this on Facebook today. Poor guy suffered a clot because his machine was off.

Maybe if he’d have known ahead of time, he could have avoided the inevitable wrong reading.

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.

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!!

And that clot he suffered from could have been a stroke or a PE and could have killed him.

Is it really worth the risk people?

Source: http://www.facebook.com/APSFA

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.

The next 4 posts are my findings from this new source…link is in most of the posts.

Do they make you mad?

They should.

I don’t understand how people can still advise other people on how wonderful these machines are. They’re inaccurate. Plain and simple.

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”.

Let me say that again. The company that makes these machines allows for 10-30% error and still calls that “accurate”.

Does that seem wrong to anyone else.

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?

Probably not.

Yet, you’ll use a machine that could be wrong 10-30% of the time to test someone as important as YOUR BLOOD.

Repeat that. Does it even make SENSE?

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.

         Because that clot or bleed may be your last.