FDA warns of glucose monitoring technology
The FDA has notified healthcare professionals of the possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips on patients who are receiving therapeutic products containing certain non-glucose sugars. The sugars can falsely elevate glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death.
From 1997-2009, the agency received 13 reports of death associated with GDH-PQQ glucose test strips, in which there was documented interference from maltose or other non-glucose sugars. The deaths occurred in healthcare facilities.
Six of the 13 deaths have occurred since 2008 despite the FDA’s efforts to communicate the risk. Ten of the 13 patients were receiving Extraneal (icodextrin) peritoneal dialysis solution for renal failure. Three of the 13 patients were receiving maltose-containing substances; one was receiving Potacor R, one was receiving Octagam, and another was receiving an infusion that contained maltose.
GDH-PQQ glucose monitoring measures a patient’s blood glucose value using methodology that cannot distinguish between glucose and other sugars, the FDA said. Certain non-glucose sugars, including maltose, xylose, and galactose, are found in drug and biologic formulations, or can result from the metabolism of a drug or therapeutic product.
The FDA Public Health Notification provides a list of GDH-PQQ Glucose Test Strips and recommends that healthcare practitioners avoid using the test strips in healthcare facilities or take steps to never use them on patients receiving interfering substances.
From 1997-2009, the agency received 13 reports of death associated with GDH-PQQ glucose test strips, in which there was documented interference from maltose or other non-glucose sugars. The deaths occurred in healthcare facilities.
Six of the 13 deaths have occurred since 2008 despite the FDA’s efforts to communicate the risk. Ten of the 13 patients were receiving Extraneal (icodextrin) peritoneal dialysis solution for renal failure. Three of the 13 patients were receiving maltose-containing substances; one was receiving Potacor R, one was receiving Octagam, and another was receiving an infusion that contained maltose.
GDH-PQQ glucose monitoring measures a patient’s blood glucose value using methodology that cannot distinguish between glucose and other sugars, the FDA said. Certain non-glucose sugars, including maltose, xylose, and galactose, are found in drug and biologic formulations, or can result from the metabolism of a drug or therapeutic product.
The FDA Public Health Notification provides a list of GDH-PQQ Glucose Test Strips and recommends that healthcare practitioners avoid using the test strips in healthcare facilities or take steps to never use them on patients receiving interfering substances.