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

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.

The conversation took place in early June and then late July.

It’s a little long, but worth a read.

Person A will be bolded and they are the original poster.

Person B is the other person who saved the conversation and their parts will be italicized.

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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.

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!

Some text has been removed to protect the identities of both parties.

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Person A:

OK, now i can receive info on specific articles that clearly say don't use finger stick inr units...??
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!

Person B:

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) 

Person A:

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.

Person B:

Here is the information on INRatio:
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)…
Along with the substances that interfere: http://www.hemosense.com/docs/5500259_TechBull104_InterferSubst_RevB.pdf
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.

Person A:

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 !!
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???

Person B:

So, my information was correct.
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.

But my Factor X and Factor II matches my vein draws.
Read the information from the manufacture of the machine, please.

Person A:

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..
Thanks

Person B:

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.

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.

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.

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.

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.

Good luck

Person A:

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....

Person B:

It is on the internet, it is searchable. …(information removed)… 
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.
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.
It is the finger stick machines. There are tons of documented incidents of these finger stick machines reading wrong.
0.8 is really a HUGE difference.

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Then Person A came back a couple days later with the following information. This is still all in YouTube comments.

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Person A:

MEDWATCH problem reporting ....MAUDE database :
Manufacturer and User Facility Device Experience (MAUDE) Database ...
... variability for inr testing. Therefore, further testing is not required at this
time. Per text "pt has antiphospholipid antibody syndrome, (cardiolipin-positive ...
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=827524 - 19k
MAUDE Adverse Event Report
... 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 ...
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=812419 - 32k
Manufacturer and User Facility Device Experience (MAUDE) Database ...
... variability for inr testing. Therefore, further testing is required at this time.
In troubleshooting found that the pt has antiphospholipid antibody syndrome. ...
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=992049 - 21k
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...

Person B:

OMG - this a great find. …(information removed)…

So I’m not nuts then, am I? I know it sounded nuts...but no, they are not good for APS patients.
My guess is, your wife will no longer being using a finger stick machine anywhere.

Person A:

changes in management will be forthcoming....yes thank you.

Person B:

Good to hear!!

Person A:

http://www.devicelink.com/grabber.php3?URL=http://www.devicelink.com/mddi/archive/08/11/006.html
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

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Then Person A came back almost a month later and the following conversation occurred. This is still all in YouTube comments.

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Person A:

filing complaint with maude database fda

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..

Person B:

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.
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.
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.
Yet, your doctors are still letting your wife use these machines?

BTW, you are still allowing your wife's doctors to use these machines?

Person A:

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?

Person B:

Go for it. Yes, I do believe it is fraud. 
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.
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.

Person A:

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!!!

Person B:

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.

So, no, I know my vein draws are accurate.

Person A:

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.
Boyd Clark, OD

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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.

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.

I have to contact my source for the first story and see how they want it posted.

Once I get the clarification, I will post the two updates.

Check back soon. They will be worth it.

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.

http://clinicaltrials.gov/ct2/show/NCT00878137?cond=%22Antiphospholipid+Syndrome%22&rank=8

Ok…a few things about this study.

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.

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. http://www.fdanews.com/newsletter/article?issueId=10981&articleId=100900

So…why the Invite Only? And who’s doing the inviting?

Are they getting a good mix of patients? Who knows…

I guess we’ll have to wait for the results of the study to come out.

Sounds like a bunch of butt covering to me.

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!!

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.

I’ll be awaiting the results and will update when they come out. I’m curious to see what the findings are.

Did a little more light reading. Have more to add as far as this topic goes.

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.

I found the following little blurb interesting:

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:

The presence of anti-phospholipid antibodies (APAs) such as Lupus antibodies
(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.

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.

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?

Would you be willing to bet your life on it?

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.

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?

You're putting a lot of faith in a little machine that the manufacturers warn is not completely accurate for APS patients.

What about those people who don't have a positive LA....what would then make their tests be off? Something to ponder.

Next statement:

The exact wording is:

Studies indicate interferences may occur in patients with antiphospholipid antibodies or antiphospholipid syndrome.

- 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.
- 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.
- Perry SL, Samsa GP, Ortel TL, 2005. Point-of-care testing of the international normalized ratio in patients with antiphospholipid antibodies.
Thromb Haemost. Dec; 94(6):1196-202.

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.

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.

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.

On to the third statement:

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.

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?

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.

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.

I'll leave you with a different kind of quote. From a different source, obviously. (not my words)

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!

And one more...(not my words)

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!

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.

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!!

Let's take example #1 for instance:

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.
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.
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.

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.

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?

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?

So convenience basically is worth the risks of an inaccurate test and a possible bleed/clot?

I guess it is for some people.

Another example to consider:

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"
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.

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?

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.

On to my third example:

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.

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.

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?

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?

Would you pick a doctor who misdiagnosed people 33% of the time?

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.

Educate yourself before you buy into this INR machine business. Convenience isn't always the "best" way.

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:

• Stool softeners "may" cause diarrhea.
• Condoms "may" stop the transmission of STDs.
  

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*

Ahh....another machine not working.

i also have aps, history of one stroke, with recurrant clots while on coumadin.
i had the protime, and when checked against the lab, was found to be faulty.
i was told by the company that it may be inaccurate for people with the lupus anticoagulant.
be careful, and once in a while check it against the lab. the differences i had were alarming.
the company apologized, said i shouldnt use it, and refunded my money. that was in 01.

Originally posted on Healthboards:
http://www.healthboards.com/boards/archive/index.php/t-352980.html

Every 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.

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.

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.

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.

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?

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…

Is the convenience of having the machine at home worth risking your life over?

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.

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.

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.

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?