FDA Says Certain Glucose Test Strips May Produce False ResultsAug 14, 2009 | Parker Waichman LLP
Federal health regulators are warning that GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) glucose meters or test strips should never be used by anyone who is being treated with drug products or therapies that contain certain sugars other than glucose. According to the Food & Drug Administration (FDA), doing so could produce a falsely high (elevated) result.
GDH-PQQ test strips are sold by a number of medical firms. A complete list of currently available GDH-PQQ strips is available here.
According to the FDA, diabetic patients who receive drug products or therapies containing certain sugars other than glucose could experience serious, although rare, injuries if they use blood glucose meters with GDH-PQQ test-trip technology. Such strips will react with certain non-glucose sugars, including maltose, galactose and xylose, and produce a falsely high result. If a diabetic patient then takes too much insulin because of this falsely high result, it could lead to abnormally low blood sugar (hypoglycemia), coma, or even death. In addition, if blood glucose is actually low, it could go unrecognized and untreated. Low blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death.
From 1997 - 2009, the FDA received 13 reports of death associated with GDH-PQQ glucose test strips in which there was interference from maltose or other non-glucose sugars. The deaths occurred in healthcare facilities. Some reports indicated that serious patient injury, such as low blood glucose (hypoglycemia), confusion, neurologic deterioration, too little oxygen in the tissues (severe hypoxia), brain damage and coma, occurred prior to death.
Drugs and therapies that contain non-glucose sugars include:
Extraneal (icodextrin) peritoneal dialysis solution
Some immunoglobulins: Octagam 5%, Gamimune N 5% **, WinRho SDF Liquid, Vaccinia Immune Globulin Intravenous (Human) and HepaGamB
Adept adhesion reduction solution (4% icodextrin)
BEXXAR radioimmunotherapy agent
Any product that contains, or the body breaks down into, the sugars maltose, galactose or xylose
Certain patients may be more likely to be using drug products or therapies that contain other sugars, including those who:
are on peritoneal dialysis
have recently had surgery
The FDA said it is working with manufacturers to address patient safety problems with GDH-PQQ glucose test strips and will continue to monitor adverse events associated with these products.