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

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

Source: http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=8883

…even though there is usually between 0.1 and 0.5 difference between a venous reading and my monitor…
Read on people…read on.

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
now here is the question: what kind of machines are you using for self-management and how precise are they?

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.
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.
Hope that helps.

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?
Seriously? Are you seriously telling me that you put your trust and your LIFE in the “hands” of a machine that’s usually WRONG??
Oh, you’ve got to be kidding me.

Source: http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=8883

Source: http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=9725

Hmm…maybe THAT’s why the machine is giving false readings…hmmm

I have been getting odd results from my machine, and have typically lost my handbook
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
click here http://www.poc.roche.com/en_US/pdf/09-112_...XS_UMDC_PST.pdf

Thanks …… i have been having the same problem...will give it a try

where do you get your alcohol from?

i just used water...but its still not correct...5.5 at home and 6.1 at the clinic !

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!!!
Hahahaha….WRONG WRONG WRONG people!! THE MACHINES DON’T WORK CORRECTLY FOR APS PATIENTS!!!!!!!!!!!!!!!!!!!!!!!!!!!

Source: http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=9725

Source: http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=9796

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.

Can u hear me screaming !
Had inr Clinic this afternoon...my machine said 5.3...the clinic 7 !!!
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
I told her my machine is pretty much spot on apart from these last few weeks....
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....

(sorry) to hear that you are having trouble at your inr clinic.
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.

It is quite common to get different readings from different machines...
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.
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!

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?
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)
will let you know how i get on, hope they can help us both, is yours still under guarantee?

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?
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.
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?
Do let us know what they say.

well seems the girl was calling me from a call centre in Germany !
Spoke with …… who has given me a phone num which i have called and left a message.
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
if she had spoken to someone who is not familiar with an high inr she would have scared them for sure.
don't get me wrong …… i am not blaming Roche just saying that i was given confusing information.
My machine as always been spot on when checked against the finger prick at the clinic.
…… anti bio do make a diiferance to our inr...
anyway hopefully going to have a venous test tomrrow so will let u know how it goes

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...
I have found Roche are pretty good and the machines are usually quite accurate.
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?
Let us know how you get on

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.  
my inr is just dropping so maybe it is the antibiotics, thanks honey, totally didnt think of it
its great this site eh, we keep each other going eh

thanks chick, but they have just called me
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.
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.
So sounds fair to me, will clean it and see what happens next smile.gif
and hope your venous samples ok chickie, i have mine done everytime like that at the hossie too

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.
then record the results and phone them with what they are.
so will see what happens next!?

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?
the code i have at the mo is 267, wondering if yours is the same batch?
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!

wonderful news that you have gone to all that effort honey...sometimes it pays off to just do a few more comparison tests.
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.
…… hope you manage to get the probs with your machine all sorted.....check the strips like …… mentioned

update...
new test strips and chip and its still out.
Hospital test from yesterday 4.1...mine 4.9
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 !!
my inr mon was 7 and 4.1 yesterday ...but i missed a dose mon ...it had to be done...
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 !!
inr clinic later today

omg! really they did that! yuk!!!
glad they are sending you a new machine

hiya what number did you call please hunny?
they are saying that 1.0 is ok for the machine to be out, and that they are different readings to the hospital inr
apparantly its like comparing celcius to farenheit?
dead confused!

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.
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!
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?!
Hell, how do you EVER know it’s accurate unless you do comparison draws every.time.???

Source: http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=9796

Source: http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=5477


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.

And they’re trying to sell them to you.

CLICK HERE TO VIEW THE ROCHE WEBSITE
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Join…see for yourself. http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=5477

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.

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.

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). 

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.

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.
Here’s the answers she got:

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.

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.

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.

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.

I know of some surgeries that use the Coagucheck machines for routine INR tests so the word is spreading slowly.

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.

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.

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!

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.

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.

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.

It does seem to me that doctors who know much about APS support the self-testing for those who can manage it.

“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!
and:

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).
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?

Thank you,….you ARE correct!!
Another sensible answer:

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.

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.

I hope you get it figured out and find a good doctor. It makes a huge difference haven't doctors who understand the illness.

*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!!!

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.

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.

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!!!!

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.

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.

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.

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.

And for the last one…let’s not blame the machine, let’s blame the antibodies. *smacks head* When will people learn?

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.

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.

All quotes taken from APLSUK & APS-SYNDROME…both yahoo groups. Happy reading!

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.

-----------------------------------------------

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.

--------------------------------------------------

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.

-------------------------

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

--------------------------

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

--------------------------

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

-------------------------

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

---------------------------------

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.

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

These are excerpts taken from a thread in the APS Friends and Support forum located at www.apsforum.com.

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.

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.

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

http://www.apsforum.com/forum25/10469.html
(registration required)

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.

I recently purchased a self testing device called CoaguChek XS. It is
manufactured by Roche and I purchased it via Tapestry Medical in Livermore,
California.

I was so excited to finally convince my doctor to give me a prescription for
the device. Even though I had to pay for it myself (it cost $2300 and my
health plan would not pay for it), I thought it would help me to regulate my
INR.

My doctor suggested that I continue getting vein draws at the lab while I'm
also testing at home for a while to verify the reliability of the machine.
The first time I tested last week the difference between the lab draw and
the self test (conducted within 30 minutes of each other) was only 0.3 so I
was highly encouraged.

Unfortunately, a week later and the second time I tested, the CoguChek said
my INR was 4.3 but the vein draw said only 3.5. For me this is a
significant difference because at 4.3 my meds are reduced but at 3.5 I stay
at the same dosages until the next test.

I called Roche and expressed my concerns about the reliabilty 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.

I feel like I wasted $2300 and I think the company should have told me that
the machine doesn't work well for people with APS. I'm frustrated with
myself for making this purchase without doing more research.

I'm sharing this with all of you in hopes that I'll be able to prevent
someone else from wasting their hard-earned money.

By the way, I'm asking the company for a full refund and if they refuse I am
going to file a claim in Small Claims Court.

- Jeanette in California

Originally posted on APLSUK (registration required) http://health.groups.yahoo.com/group/APLSUK/message/49519

Written by Todd's wife, Heidi in the APS Friends & Support Forum

Or for those people who are thinking about getting one...

PERFECT EXAMPLE of how they just DO NOT work with APS patients....

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.

Well, Todd hasn't been feeling well. for a week or so now... Went to get an INR drawn...usual way, finger stick in the lab. INR came back 3.9

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.

Anyhow...he starts getting right side numbness WITH the Migraine that he had.

Goes into the ER...

Well folks...they did a VEIN draw...Guess what his INR was???? 1.5!!!!

ONE POINT FIVE????? omg

That is a HUGE difference...HUGE!!!!!

So he had a TIA everyone.

I'll tell you this. I am going to be on the phone 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.

He hasn't had a TIA since APRIL!!!

So, please anyone...tell me again WHY you want a machine?

Here's a thread to read also... http://www.apsforum.com/forum25/6543.html
(registration required)

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!

Original Post: http://www.apsforum.com/forum25/6943.html (registration required)

And in his own words:

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. 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.

Brand of Machine: Roche CoaguChek S™
Diagnosis: SNAPS
Experience: 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.

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.

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.

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.

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 informed decision. This is your life and it could be your death that these machines could cause.

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.

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.

The rest of the companies have their information readily accessible. Thank you for keeping it real and not hiding the information!

Happy Reading. Use these machines in general at your own risk. 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.

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. Buyer Beware!

Click here to see this story on Tina's Website