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FDA Issues Warning for Certain Diabetic Test Strips

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Diabetics are being warned to avoid using certain glucose monitoring test strips if they are being treated with drugs or therapies that contain certain sugars other than glucose.  According to the Food & Drug Administration (FDA), test strips with  GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) technology so could produce a falsely high (elevated) result in such patients.

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.

GDH-PQQ test strips are sold by a number of medical firms.  A complete list of currently available GDH-PQQ strips is available here.

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.

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