FDA warning – fatal errors with some glucose test strips

27Aug/091

FDA warning – fatal errors with some glucose test strips

I received a public health notification this afternoon from the FDA. You may get high blood glucose test results if you're using test strips based on GDH-PQQ and you're taking medication that contains non-glucose sugars. Note: this is not a recall, it's a warning.

The partial list of medications includes:

Extraneal (icodextrin) peritoneal dialysis solution
Some Immunoglobulins: Octagam 5%, Gamimune N 5% (no longer distributed in US), WinRho SDF Liquid, Vaccinia Immune Globulin Intravenous(Human), and HepaGamB
Orencia (abatacept)
Adept adhesion reduction solution (4% icodextrin)
BEXXAR radioimmunotherapy agent
Any product containing, or metabolized into maltose, galactose or xylose. (Usually over the counter products)

The FDA has provided a list of test strips affected by this warning. These include: many Accu-chek products; Abbott FreeStyle strips, including those for the Cozmo and Omnipod insulin pumps; and TRUEtest strips.

If you're affected by this warning and you encounter a false high reading, you can report issues directly to the FDA.

If you're not affected by this warning, it's a good reminder to wash your hands before testing. It's way too easy to get a false high reading because of foodstuff on your fingertips.

You can subscribe to these kinds of warnings but very few of them are related to diabetes devices, just fill out the simple form on this FDA subscription page.

Update: I received several press releases on this issue from various manufacturers of blood glucose test strips. Assuming it's reasonably accurate, the most useful is this document (PDF) from Roche Diagnostics. Table 2 below (click to see it in a readable size) lists some of the drugs that can cause maltose interference, about how many people are using them, and how they're delivered. Most of these drugs are used in hospital settings. From this table it seems like Extraneal users is the group most likely to have people with diabetes, and I'm assuming hospitals have been notified.

Bayer has posted a press release to say that their products are not affected by this warning. I spoke with someone from Agamatrix (makers of WaveSense meters) and their strips are also not affected by this warning as they use glucose oxidase.