Coaguchek - Roche

The machine (actually unidentified lots of the test strips used in the machine) in question is the Coaguchek S from Roche. I don't know if there are problems with any of the other coagulation monitors out there... But Roche is suggesting duplicate testing with different lot numbers for each patient getting a Point of Care INR with the machine. Out of 60 or so tests since the "Product Alert" was issued and enforced by the FDA last week, only 2 had the same result between lot numbers.

Roche provided paramaters for when to send the patient to the lab for a confirmation of the INR, and none of the results have been outside that range. Even with discrepancies as high as 29% between two lot numbers. The range seems dangerously generous to me. For example, an INR result of 3.0 on one lot of test strips and 3.9 on another lot of test strips on the same patient at the same time would be within the acceptable range of discrepancy. Or worse, if one lot number reports 1.6 and the other 2.0, this is within acceptable discrepancy margins as well.

Coumadin dose adjustments are based on the results! The protocols where I work indicate to change the Coumadin dose by a certain percentage for an INR of 1.6 or 3.9 (or anything out of range). But, according to Roche, these results are acceptable? It just concerns me, and if I was a patient on Coumadin I would not be getting a fingerstick right now! I'd be going to the lab for an old fashioned veni-puncture.

Just wondering what others using the Coaguchek are doing. And if you think I am being too stringent. Thanks.

Here is the product alert link supplied by Roche. I also checked out the one the FDA has issued and the content/information is the same. There are 2 alerts issued 10/19/06; one for product alert and another for suggested duplicate testing parameters (those are the ones we are using and I am not comfortable with).

http://www.coaguchek-usa.com/product...ion/index.html