FDA warns of falsely elevated blood glucose results with GDH-PQQ test strips

Late yesterday, the FDA notified health care professionals of possible falsely elevated blood glucose results with the glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ) glucose test strips in patients receiving therapeutic products with certain non-glucose sugars.

These sugars, including maltose, xylose and galactose, can falsely elevate glucose results, masking hypoglycemia or prompting excessive insulin administration, leading to serious injury or death, according to the FDA. GDH-PQQ glucose monitoring uses a methodology that cannot distinguish between glucose and other sugars.

A list of the test strips that use this methodology is available on the FDA website.

The FDA recommends that health care practitioners avoid using GDH-PQQ glucose test strips in health care facilities or take steps to never use them in patients receiving interfering substances. The interfering products include:

icodextrin (Extraneal, Baxter) peritoneal dialysis solution;
some immunoglobulins: Octagam 5% (Octapharma), Gamimune N 5% (Bayer), WinRho SDF Liquid (Baxter), Vaccinia Immune Globulin Intravenous(Human) (Cangene), and HepaGamB (Apotex Corp.);
abatacept (Orencia, Bristol Myers Squibb);
4% icodextrin (Adept adhesion reduction solution, Baxter);
tositumomab (Bexxar, GlaxoSmithKline) radioimmunotherapy agent; or
any product containing, or metabolized into maltose, galactose or xylose.

The FDA also urged health care practitioners to voluntarily report any medical device adverse events related to glucose meters or test strips that do not meet the requirements for mandatory reporting. Adverse events can be reported on the FDA website.