ITC ProTime Meter Strip Errors -- WARNING

[Protimenow]

I'm rather disappointed. I was working under the assumption that testing with the ProTime meter - although not as easy to do as with the InRatio or CoaguChek XS, would give values that are closer to lab values than the other meters.

After having a TIA (aka STROKE) in April, partly because I trusted my meter to be accurate and didn't know that a 2.7, in some cases, meant 1.7, I decided to try testing with the ProTime meter, which uses a different method of determining prothrombin times.

My experience with parallel testing - ProTime, InRatio, and sometimes, Lab, provided results on the ProTime that were below labs and far below InRatio. After having multiple tests on the ProTime give very low results when compared to the lab, I contacted ITC, the manufacturer of the ProTime meter and strips (they call them Cuvettes). They didn't seem interested - or concerned - and it seemed as if my report of inaccuracy fell on deaf ears.

I don't recall them asking for a lot number, and they certainly didn't suggest that they replace my possibly erroneous cuvettes.

Today, I learned from the distributor who sold me the cuvettes that ITC issued a recall order on these cuvettes - dated nearly a month ago. Certainly, the potential harm that results from adjusting dosage for an INR that is LOWER than labs would have less negative impact than one that reports HIGHER than labs (as I can say from personal experience with the InRatio), but it would have been better if ITC seemed to care about my report, and if I would have been notified of the recall a few weeks earlier than today.

If ANY of you are using ProTime cuvettes - check with your source or ITC and make sure that your strips aren't in the possibly erroneous lot(s).

 

[Lynlw]

I'm rather disappointed. I was working under the assumption that testing with the ProTime meter - although not as easy to do as with the InRatio or CoaguChek XS, would give values that are closer to lab values than the other meters.

After having a TIA (aka STROKE) in April, partly because I trusted my meter to be accurate and didn't know that a 2.7, in some cases, meant 1.7, I decided to try testing with the ProTime meter, which uses a different method of determining prothrombin times.

My experience with parallel testing - ProTime, InRatio, and sometimes, Lab, provided results on the ProTime that were below labs and far below InRatio. After having multiple tests on the ProTime give very low results when compared to the lab, I contacted ITC, the manufacturer of the ProTime meter and strips (they call them Cuvettes). They didn't seem interested - or concerned - and it seemed as if my report of inaccuracy fell on deaf ears.

I don't recall them asking for a lot number, and they certainly didn't suggest that they replace my possibly erroneous cuvettes.

Today, I learned from the distributor who sold me the cuvettes that ITC issued a recall order on these cuvettes - dated nearly a month ago. Certainly, the potential harm that results from adjusting dosage for an INR that is LOWER than labs would have less negative impact than one that reports HIGHER than labs (as I can say from personal experience with the InRatio), but it would have been better if ITC seemed to care about my report, and if I would have been notified of the recall a few weeks earlier than today.

If ANY of you are using ProTime cuvettes - check with your source or ITC and make sure that your strips aren't in the possibly erroneous lot(s).

Do you have a link to this recall, with lot info etc? There is nothing o their site that I saw at least

 

[Protimenow]

I have a PDF that was sent to me by the distributor who sold me the strips. For some odd reason, the recall notice that I got REFERRED to lot numbers in a certain range 'on the attached table' but no table was attached. I'm assuming that the distributor kept track of the lot numbers that it shipped, so it knew which lots were part of the recall.

If you like, I can probably send you the PDF file for your review, but I don't have the specific lot numbers. FWIW the lot number of my cuvettes - probably one of those in the recall group - is B2P3C042. The expiration date is 2013 - 02.

I'll contact my distributor and see if they got a table of lot numbers in the recall. (The dealer that sold you your cuvettes SHOULD have the lot numbers).

I'm not sure if they'll be replacing the cuvettes one for one, or if they'll send a box to replace a partial box.

Apparently, they aren't offering the 3 channel strips until they work this out. I haven't tried the 5-channel, but I know that they take a lot more blood, so they may be a bit more hassle to get a good test. (Of course, since our lives kind of depend on accurate results, it may be worth the hassle). (I'd still like to try a CoaguChek XS and test it for accuracy).

Lyn -- if I can get the information about specific ranges of 3 channel cuvettes are affected, I'll post it here.

 

[Lynlw]

Thanks, I dont need the info, I just thought it was odd they dont have it posted everywhere, hec when my dog's treats are recalled it makes the news and the manufacturers have to put it on their sites.. The only thing I could find was the stuff from 07 when they FDA wrote them several warning letters and they where talking about recalling the actual protime machines nothing about the recent cuvette problem, at the very least you would think suppiers would notify customers they sold the recalled strips to.

 

[Protimenow]

This is a follow-up:

The distributor who sold me the original 3-channel cuvettes contacted me. This was how I found out about the recall.
I assume that clinical users of these cuvettes have all been contacted by their suppliers. I assume that if there are ANY home testers using the cuvettes, that they would also have been notified (but the way this was set up, I'm not sure if the notifications went all the way down to home testers).

I filled out the form that was sent by the manufacturer of the cuvettes and emailed a copy to my supplier. Last week, I received a box of 5 channel cuvettes, and mailed back my remaining 3 channel cuvettes. My first test with the five channel (which is supposed to be very close to lab results) was a 2.9. My InRatio, testing at the same time, gave me a 3.1. I'm inclined to trust the new 5 channel cuvette more than I do the InRatio (although I trust the InRatio to be a BIT high on every test, so the results of both tests makes me comfortable that I'm in range).

As far as publicizing the recall -- I'm not sure that there was any press -- but there may be so few ProTime meters in use that are NOT being provided strips by the distributors, who made the appropriate notifications, that there would have been a lot of benefit to publicizing the recall.

 

[Protimenow]

This is another follow-up.

A month or two AFTER I returned the flawed 3-channel cuvettes, ITC called and wanted a tracking number for the UPS shipment that I made, back to the distributor. After a couple momths, I didn't keep the receipt. I told them to check with the distributor -- this was who I returned those cuvettes to.

It didn't seem as much that they cared that these dangerous cuvettes might still be in use as it was that they were thinking of charging for another ripped-off box of cuvettes. (Of course, their motivations could have been more than just bean counting, tut I wasn't asked 'did you throw them out?')

I still have many of the 5-channel cuvettes and will be using them to validate results against lab, InRatio, and my soon-to-arrive Coag-Sense meter. One day, maybe I'll have a CoaguChek XS.