Pulmonary Embolism Support Group

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InRatio 2 and test strips

Ferr
Ferr
Has anyone else who uses or has used received a letter from the manufacturer about their InRatio 2 monitor and test strips and the fact the PT/INR readings have not been accurate. They are claiming in the letter I got to stop using the monitor & test strips, and discuss with my doctor having the lab draw my PT/INR. Apparently the results the monitor reported were below accurate levels. In other words if the monitor read 2.3 your INR could actually have been 4.6. On November 11 2013 I checked my PT/INR and the reading was 3.3 well within my levels of between 2.5-3.5 I had a serious brain bleed that day and when I was in the ER later that morning and they checked my PT/INR is was over 6.0. I was given several doses of vitamin K and put in the ICU for 3 days hoping the bleed would stop on its own and doctors wouldn't have to go in and evacuate the bleed. Luckily for me the bleed did indeed stop but not before causing permanent damage to the right ocipital lobe of my brain leaving my with no peripheral vision in my right eye, no depth perception and a smattering of emotional problems common with stroke victims. After being off Coumadin for 6 months they were talking about putting me back on but decided to try the Xarelto instead which can present a whole bunch of new difficulties in itself. The one good point is not having to check my PT/INR anymore, the bad is the medication cannot be reversed but is out of your system in 18 hours. I have been on the Xarelto since May of 2014 and seem to be doing fine. I know many of you are probably thinking then why worry about your InRatio 2 Monitor since you no longer use it. Well, just that the warning came like a year to late for me, could the fact the monitor gave false readings be in part why I had the brain bleed? All those times I thought I was just a little high when my PT/INR levels were at maybe 4.0 were they really 8.0?
ShilosMommy
ShilosMommy
Wow, Ferr, that's crazy. I'm not generally a litigious person, but if I were you I'd be talking to a lawyer, seriously. I mean, if you took your INR that day showing you within your limits, but got a brain bleed and upon admittance to the hospital had your INR measured over 6 at the hospital, I'd say you have pretty clear proof of the discrepancy. And I think, yeah, the chances are pretty good that the too-high INR was a factor. Had your doctor at any point talked about that with you, the fact that your INR was so high and that it might have contributed? Especially I'm wondering if the fact that you likely had a consistently very high INR, whether that could have somehow had an effect on the blood vessels themselves which eventually caused the hemorrhage. I mean, I don't obviously know anything about it for sure, but if I were in your situation, I'd be talking to the doctors, etc. about it. Because although I'm sure you feel fortunate every day that the situation wasn't worse, you do have brain damage as a result, and that affects your life in more ways than I can probably even imagine.

How have you been doing since we heard from you last?
cave76
cave76
Here is a pdf of that letter that Alere sent out.

http://www.inr-care.com/content/dam/web/inratio/FINAL_INRatio_Patient_Self_Test_Customer_Letter-DEC_10_2014.pdf

In it you are told to discuss this with your doctor.
You're also told just which home monitor and test strips were involved. (Mine wasn't one of them.)
rmb
rmb
What's interesting to me in that letter is the listed health conditions where they recommend using a lab INR method instead. I wonder if that's recommended regardless of what brand home monitor is used?

I don't home test. I just never really looked into it seriously and my Hema thought it wasn't a good idea for me because of reliability of the results. I wonder if he was thinking in terms of my inflammatory disease history.
ShilosMommy
ShilosMommy
I wonder if hematologists are just more generally cautious regarding the home monitors? Because although my cardiologist was agreeable to me doing home testing, the hematologist was completely against it and said he wanted me doing blood draws.
rmb
rmb
I think that's more it, actually. He wasn't testing or monitoring my INR so he really didn't have anything to financially gain by having me test at a lab.

With my old doctor, she'd always do a finger prick INR test anytime I came in the office, but I had the majority of my INRs done with a lab. They INRs were always way different from each other. But my INR was kind of unstable at that time as well so it's hard to say for certain if it was a disparity between the venous draw vs the finger prick and just my general instability.
Ferr
Ferr
My doctor always did a finger test strip test too when I had an appointment, but I didn't always see him monthly. And yes we had questioned the accuracy of my monitor and actually had called Alere and asked about how to check to see if it was calibrated. They told us to just check it against lab tests which we did. But then again this inconsistency wasn't discovered on my monitor until about the 2 months before my bleed and leading right up to my bleed. My monitor is not on the list and we have no record of which strips were used as towards the end I was testing more frequently and all I have left of strips is a new unopened box.. I know my doctor is furious and wrote a letter which he sent copies of my lab tests with to compare against the monitors readings showing how inconsistent the PT/INR's were. As far as using the monitor I did so because I live so out of the way and not close to town and was often out traveling in the woods trying to lead a normal life. When i started back to work at the hospital I could have had my PT/INR checked but my readings were within normal range (we thought) and the doctors were OK with that. It was a total fluke we discovered the discrepancies. Not sure what we are going to be doing about it as i have so many other things on my plate at this time but I can assure you it wont just be dropped. This has messed up my life to unimaginable limits.
Ferr
Ferr
Shilo, the hematologist at the hospital was totally against home monitoring too but mainly because they are the ones who run the Coumadin clinics. Les people coming to the clinics less money in their pockets. Oh and Also feel free to read my journal entry, LOL Kind of long but it gives a run down of life in the PE Lane, well at least my life LOL
cave76
cave76
@Ferr

You said: "we have no record of which strips were used "

Not that it will affect you now but just for the knowledge----- I'm pretty sure Alere can tell you what strips you used in the past. IF they would!
lucy0100
lucy0100
The guy I buy my protime 3 strips told me that Alere had a "bad batch" of strips. I was looking to change machines (because my insurance would have to pay 100% for it) and he told me that Alere will not be selling to medical supply places anymore and you would have to get them straight from Alere for about $25.00 per strip instead of the $5.00 I pay now, so I opted for the Coagucheck.

I have a venous draw every three months and check it against my monitor. My Protime was +.3 over the correct INR, so I just subtracted that from my reading and it was accurate for me that way.

So sorry about what you had to go through and yes I would be talking to a lawyer and sue them. You can do a search to see if any suits have already been brought against them. Good luck!
IdaRed
IdaRed
What Ferr didn't add was that the letter asks you to check one of 3 boxes, 2 of which add "i will take no further action", sign and return to them.
Ferr
Ferr
IdaRed you are correct, and since I didn't manage to keep 3 boxes of test strips on hand I I seriously doubt Alere is going to furnish me with the information on which test strips I had. Anyway I left it to my doctor to reply to the letter and tuned the rest of the information along with the letter over to my Attorney. And no I signed nothing
Tian71
Tian71
Scary! I use CuaguCheck at home monitoring. Almost makes me want to get checked at the doctors every now and then just to "make sure"!
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