Alere issues 'Voluntary Urgent Correction' regarding InRatio tests

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Protimenow

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On December 3, Alere apparently sent out a 'Self Test Customer Letter' to some (probably not all) of its self-test customers. Alere is aware that, for a while, I was using the InRatio, but I haven't received the letter. Perhaps only those who use the Alere blood monitoring service were included in this letter.

he title of the letter is "URGENT:MEDICAL DEVICE CORRECTION", and it reports that 'in certain cases an InRatio..system may provide an INR result that is significantly lower than a result obtained u sing a laboratory INR system." (This information is contrary to my personal experience with the InRatio, which was always higher than the labs or my Coat-Sense meter).

The letter goes on to state that the issue can arise if you have certain medical conditions -- these inlude Anemia, acute inflammatory conditions, chronic inflammatory conditions (rheumatoid arthritis, Crohn's disease, and other fun ailments), severe infection, advanced stage cancer or end stage renal disease, or any bleeding or unusual bruising.

The notice goes on to suggest that you discuss this with your doctor, and also suggests that you have your INR tested using a laboratory INR method.

I don't have a link for these notices, but Alere has established an 'Alere InRatio Recall Hotline' at 877 929 2579, and a website with answers to frequently asked questions -- www.inr-care.com.

I won't speculate on how this information, combined with a strip recall and limited availability of strips will impact the future of the InRatio devices for testing (self-testing, or testing at medical facilities) INR.
 
After I had submitted my last inRatio 2 test result, my clinic asked me to call them regarding my result. They asked me which machine I was using, and when I said I had the inRatio 2, then informed me of the recall and that I should stop using the inRatio 2 immediately. I explained I would be traveling abroad for another 2 weeks and could not understand how taking a drop of blood could be dangerous, but trying to talk some sense into them was useless. (i'll just test as usual, and not report the result back to them). In any case, they explained I would receive a replacement machine once I replied to a letter sent to my home address. Hopefully the transition will be smooth as I cannot imagine having to go to the clinic after home testing for years.
 
Last edited:
realkarl;n850570 said:
I explained I would be traveling abroad for another 2 weeks and could not understand how taking a drop of blood could be dangerous,

It isn't, but being under your INR zone for periods is.

You should know this!
 
realkarl;n850570 said:
I explained I would be traveling abroad for another 2 weeks and could not understand how taking a drop of blood could be dangerous.

At the risk of really sounding ancient, this is my story of being abroad with an out of control INR. In the early 1980s my wife and I where on the southern coast of Spain for about ten days or so and one morning I noticed, what appeared to be, blood in my urine. This was in the days before INR and "finger sticks" and only labs could perform the "pro-time" test......and I was terrified to go into a hospital on the "Costa del Sol" for the test as I don't speak spanish and didn't want to be hospitalized so fan from home......a home testing meter would have been the solution. Knowing I was returnin to the US in a couple of days, my solution was to stop my Coumadin, drink a lot of water to flush my system and be very careful about what I ate and drank......and it worked. My "pro-time" tested normal when I got home. Today, I would consider my "solution" to be dangerous and pretty foolish. If I where you I'd take my meter and strips on your trip and if a test shows weird results, I'd seek local professional help.

BTW, my experience was, almost certainly, due to local foods and wine.

PS: Your INRatio meter and strips are probably OK. I was using an INRatio2 and cross checking my INRs with my doc's CoaguchekXS monthly and results where comparable.....however, because of the uncertainty about the continuing accuracy and strip availability of the INRatio I have replace mine with the CoaguchekXS
 
I got a letter from Kaiser Permanente lats week to stop using my Alere meter. I also got a phone call this morning. Frustrating because about a month ago I lab tested and self tested within 2 hours of each other and got identical results. They didn't ask for the tester back though. They just said to stop using it.
 
bocco;n850729 said:
I got a letter from Kaiser Permanente lats week to stop using my Alere meter. I also got a phone call this morning. Frustrating because about a month ago I lab tested and self tested within 2 hours of each other and got identical results. They didn't ask for the tester back though. They just said to stop using it.


Alere gives out CoaguchekXS meters as well. They should send you a replacement meter and strips. You may want to contact them or your insurance company.
 
tom in MO;n850773 said:
Alere gives out CoaguchekXS meters as well. They should send you a replacement meter and strips. You may want to contact them or your insurance company.

I assume that you meant Kaiser not Alere. There was no mention of sending a coagucheck meter instead. The person that I talked to wasn't sure how Kaiser would ultimately handle this due to the large number of meters out there. They're solution for now is back to lab testing. In my case this is not to bad as the lab is conveniently located and not to busy in the morning on the way to work. But my current Kaiser plan has a $30.00 copay. Kaiser currently has me testing every four weeks but will allow more often. I still have seven test strips and plan to alternate between lab and home so that I test every 2 weeks for the next seven months. If Kaiser doesn't come up with a better option during that time I may just buy my own coagucheck on line.
 
I received a call today from Alere that they were sending me a Coaguchek meter to replace my INRatio 1 meter and that it would be no cost to me. I thought yea right you will bill Medicare for it. They went on to say that I was to send my old meter back and informed them that I bought and paid for it nine years ago and I was keeping it. I have never had a bad reading in the years that I have owned it. Between you and me and gate post I have had a lot of reservation about Alere ever since they got their foot in the door.i.e. drying up all cheaper places to get strips etc.etc.
 
pellicle;n850575 said:
It isn't, but being under your INR zone for periods is.

You should know this!
Of course I know this..! So I gave up explaining common sense rather quickly to the person calling me from my health care provider's anti-coag clinic. And I have tested as usual with my INRatio while away.
Now back in the U.S., I had two letters waiting for me from Alere explaining the potential inaccuracy with INRatio and certain medical conditions, in case I was to continue using the INRatio. However, my healthcare provider had fortunately authorized the replacement of the INRatio with a Coaguchek unit, so I should have that early next week.
 
Hi
realkarl;n850995 said:
Of course I know this....Now back in the U.S., I had two letters waiting for me from Alere explaining the potential inaccuracy with INRatio and certain medical conditions, in case I was to continue using the INRatio
I guess my point was lost in my brevity. My point was that since the strips have been recalled and the meters too now, that the danger is you could be significantly under in your INR and not know this. I had just been discussing an issue with another member here who had congestive valve failure which seems to have been from exactly the problem of their INRatio misleading them.
 
@pellicle: yes, I completely misunderstood your post... It was my understanding the INRatio inaccuracy is triggered by certain medical conditions. What is described there though, is that the actual INR could potentially be higher than what the INRatio reports. Not being affected by any of these conditions, and those times I have measured INR in-lab and at home at almost the same time, the results have been very close, I did not consider the inaccuracy issue so critical that I needed to find an anti-coag lab while traveling. In any case, I am really glad my healthcare provider is willing to replace the equipment so quickly.
 
Hi

realkarl;n850999 said:
@pellicle: yes, I completely misunderstood your post...... I did not consider the inaccuracy issue so critical that I needed to find an anti-coag lab while traveling. In any case, I am really glad my healthcare provider is willing to replace the equipment so quickly.

in my defense I'll say that since in many cases I have to type on a tablet now (as this forum software does not function properly on my XP based browsers) I make far more mistakes in entry (hate on screen keyboards) and suffer "tunnel vision" in replying (probably because I have to type so god-damm-slow on those OnScreenKBDs) missing out whole sections of what I've wanted to say ...

anyway the main point is that I'm glad to hear you didn't have any issues :)

PS, this is the post I was thinking of when I replied in the first instance:
I am in my 16th day in the hospital post series six of TP-A for reported clot on my valve. Interesting as I self tested religiously and closely monitored my INR, bridged with care and wish I knew what happened. Unfortunately, the Dr is feeling my machine was not giving correct readings and now I am looking at going to labs. I had to get a new machine which came last week as I went on Medicare.

I brought my old machine with me which registered within .1 of lab reading. That was before starting any treatments. Then the Dr wanted me to verify more results with the lab and that's where it all went down. I was getting 2.3 per lab and one machine 4.0 and my older one 3.8. It later wouldn't even register.

underline mine.

probably I misunderstood the situation and incorrectly assumed that one of the problems with the INRatio was that you could be seeing 4 on your machine (and thus adjusting down) when the lab result of that blood sample was 2.8 (no need to adjust)

Perhaps her situation was compounded by the drug treatments ... but the mystery of why was there a clot remains.
 
http://www.fda.gov/Safety/Recalls/ucm396219.htm

Alere has received nine serious adverse event reports, three of which described bleeding associated with patient deaths. The reason for the adverse event reports was significantly different test results between the Alere INRatio2 PT/INR Professional Test Strip and the local laboratory plasma INR test. The Alere INRatio2 PT/INR Professional Test Strip results were between 3.1 – 12.2 INR units lower than the laboratory result.

as we say here in Auss-tray-li-ya "bloody nora"
 
I finally received the recall notification from Alere -- with nothing said about replacing the meter. (Of course, I didn't use their service, either - they just knew that I had an InRatio meter).

I stopped testing with the InRatio for the OPPOSITE reason to their recall -- the InRatio was reporting results that were considerably (dangerously?) higher than the labs or my Coag-Sense results. (When I had my TIA, the InRatio said 2.6, and the hospital lab said 1.7).

I stopped using the InRatio, because the results, for me, were always too high.
 
Just got my letter (1/5/24) about the recall. I contacted Stericycle which owns Alere. That was a surprise as I have contracted with them for years collecting hazardous waste at our clinic. Not sure how they got into that blood monitoring business. They were VERY insistent about picking up my new In Ratio ASAP that they gave me when I was in the hospital so they could provide me with the Coagucheck. Its wrong at any rate. Lab 5.2 In Ratio 4.8, Lab 2.8 and In Ratio 2.8, Lab 3.2 In Ratio 2.7.

I will give it to them when they come Wednesday to pick it up but I am refusing to sign any paperwork or give up the InRatio II I have used 5 years or more since stopped using my ProTime. I am wondering with 100,00 letters going out, am I the only one who got the clot on their valve due to machine not giving correct readings if anemia present? I have been through a lot since finding out in routine echo and pulmonary function tests 4/2014. This includes an harrowing hospital admission for 6 days of TP-A infusions on bed rest and hourly monitoring and another 13 day stay for further monitoring. I hate to keep harping on this but fear this may happen to someone else.

I am not out of the woods yet as have an echo and fluoroscopy coming up next month. I am hearing a click again which used to bother me but is now music to my ears! Op redo option still on the table.

Protime, they were saying results were too low?

Thank you all for being there during this difficult time.

donna
 
I was hoping to find an update on this subject of finding test strips for the Alere InRatio meter. I was getting them from eBay at $200.00 for a box of 48. Now, that will buy you 12 if you're lucky enough to find them. I was unaware of this recall drama. I've had my meter since early 2008 and to my knowledge I don't think I registered the meter with anyone. Is it safe to trust the readings and if so where can I get the strips at a reasonable price within the USA.
 
Hi

I use a Coaguchek XS, but as to safety I'd say that if you aren't in one of the "problem bloods" groups it will be as good as it ever was (for the majority)

This is the official stance here in Australia

https://www.tga.gov.au/alert/alere-i...monitor-system

Alere INRatio PT/INR monitor systems should not be used in patients with any of the following conditions:
  • anaemia of any type with haematocrit less than 30% for Alere INRatio PT/INR test strips, or less than 25% for Alere INRatio 2 PT/INR test strips (heparin insensitive)
  • any conditions associated with elevated fibrinogen levels, including:
    • acute inflammatory conditions (examples may include acute viral or bacterial infections such as pneumonia or influenza)
    • chronic inflammatory conditions (examples may include rheumatoid arthritis, Crohn's disease, ulcerative colitis, infectious liver diseases such as hepatitis, or inflammatory kidney diseases such as diabetic nephropathy and glomerulonephritis)
    • severe infection (for example sepsis)
    • chronically elevated fibrinogen for any reason
    • hospitalised or advanced stage cancer or end stage renal disease patients requiring haemodialysis
  • any bleeding or unusual bruising, either clinically observed or reported by the patient.
Patients with any of the conditions listed above who are being tested with an Alere INRatio PT/INR monitor system should immediately be transitioned to a suitable alternative monitoring device or laboratory INR method for testing.

as to ebay buying, personally I wouldn't have one even if it was free
 
The Alere strips have become extremely expensive and hard to get. Personally, based on my own personal testing, my experience has been the opposite of the one reported -- InRatio reported values that were considerably higher than blood draws. I chose, after comparison testing between the InRatio, Coaguchek XS and Coag-Sense, not to use the InRatio. In fact, I let a supply of strips go unused because I no longer trusted the meter for my testing.
At this point, you may think strongly about getting a different meter -- especially because it's hard to get strips for the InRatio (and who knows when, or if, they'll resolve that), and the other meters seem to be somewhat more accurate, probably affordable if you do enough looking, and you can get the supplies for them.
 
Hi PT, glad to see you back

Protimenow;n855351 said:
The Alere strips have become extremely expensive and hard to get. Personally, based on my own personal testing, my experience has been the opposite of the one reported -- InRatio reported values that were considerably higher than blood draws.

that is also the experience of one lady here who developed significant obstructive clotting on her St Jude valve as a result of being way under coagulation levels for an extended period. Fortunately this was reversed without surgery in her case (PICC line administration of a cocktail). This was identified as a failing in her InRatio. She now uses a Coaguchek IIRC
 

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