FDA Warns of Potentially Fatal Errors with GDH-PQQ Glucose Monitoring Technology

The Food and Drug Administration (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. These sugars can falsely elevate glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death.

GDH-PQQ glucose monitoring measures a patient's blood glucose value using methodology that cannot distinguish between glucose and other sugars. Certain non-glucose sugars, including maltose, xylose, and galactose, are found in certain drug and biologic formulations, or can result from the metabolism of a drug or therapeutic product. 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..

Other glucose test strip methodologies are not affected by the presence of non-glucose sugars. The unaffected methods are glucose oxidase, glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), or glucose dehydrogenase flavin adenine dinucleotide (GDH-FAD). To read the FDA alert, which lists all the safe glucose monitoring technologies, see the link below.

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Published on Aug-13-09