When these non-glucose sugars are present in the patient’s blood, using a GDH-PQQ glucose test strip will produce an elevated glucose result which may suggest the need for clinical action. This can lead to inappropriate dosing and administration of insulin, potentially resulting in hypoglycemia, coma, or death.

 

In addition, cases of actual hypoglycemia may go unrecognized if the patient and healthcare practitioner rely solely on the test result obtained with the GDH-PQQ glucose test strips.

 

According to an alert sent last week from MedWatch, the FDA's safety information and adverse event reporting program, the GDH-PQQ test cannot distinguish between glucose and other sugars and can "falsely elevate glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death."

 

Since 1997, the FDA has received reports of 13 deaths associated with the strips in which maltose or other nonglucose sugars were considered to play a role. Of these 13 deaths, 6 deaths in healthcare facilities have taken place since 2008, even though the FDA has taken steps to disseminate information about the risk.

 

Of the 13 patients who died, 10 were receiving icodextrin peritoneal dialysis solution (Extraneal, Baxter) for renal failure, and the other 3 were receiving substances containing maltose. As a result of the false-positive results, patients were treated with "insulin doses or insulin drips that were guided by falsely elevated results," according to an FDA Public Health Notification. Test results produced by the strips were up to 15 times higher than the corresponding laboratory results.

 

"Some reports indicated that serious patient injury, such as hypoglycemia, confusion, neurologic deterioration, severe hypoxia, brain damage, and coma occurred prior to death," the FDA states.

 

The FDA recommends that use of GDH-PQQ glucose test strips be avoided in patients who are receiving interfering products or from whom information regarding concomitant medication use cannot be obtained. Interfering products containing nonglucose sugars include icodextrin peritoneal dialysis solution, certain immunoglobulins, abatacept (Orencia, Bristol-Myers Squibb), tositumomab (Bexxar, GlaxoSmithKline), and any product containing or metabolized into maltose, galactose or xylose.

 

Several test strips and associated monitors use GDH-PQQ methodology: ACCU-CHEK (Roche), FreeStyle (Abbott Diabetes Care), TRUEtest (Home Diagnostics), CoZmonitor blood glucose module (for use with the Deltec Cozmo insulin pump, Smiths Medical MD), and OmniPod insulin management system (Insulet).

 

According to the FDA, the use of drug interaction alerts should be considered in computer order entry systems, patient profiles, and charts to alert staff to the potential for falsely elevated glucose results. Glucose meter results should also be periodically verified with laboratory-based glucose assays.

 

More information is available on the MedWatch Web site.