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.