FDA Warns on Potentially Fatal Glucose Monitor Readings

Reacting to a spate of recent deaths, the FDA has issued a public health notice regarding potentially fatal errors when testing blood glucose using glucose dehydrogenase pyrroloquinoline quinine (GDH-PQQ) glucose monitoring technology. GDH-PQQ technology does not distinguish between glucose and non-glucose sugars (eg maltose, xylose, galactose) and can “mask significant hypoglycemia or prompt excessive insulin administration.”

Of the 13 death reports that the FDA has received since 2007 “associated with GDH-PQQ glucose test strips in which there was documented interference from maltose or other non-glucose sugars,” six have occurred since 2008 despite FDA efforts to communicate risks to healthcare providers.

Patients tested using GDH-PQQ technology were receiving Extraneal (icodextrin) peritoneal dialysis solution for renal failure or maltose-containing substances. All were treated in healthcare facilities “with insulin doses or insulin drips that were guided by falsely elevated results.”

Those results, “generated on GDH-PQQ test strips, were 3 to 15 times higher than corresponding laboratory results.” In two cases, GDH-PQQ system readings generated results of 200 mg/dL and 193 mg/dL, while laboratory results indicated glucose levels of 19 mg/dL and 8 mg/dL.

“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 indicates that “other glucose test strip methodologies are not affected by the presence of non-glucose sugars.”

These include glucose oxidase, glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose dehydrogenase flavin adenine dinucleotide (GDH-FAD), and laboratory-based blood glucose assays.

Questions and concerns regarding this Notice should be directed to the FDA’s Office of Surveillance and Biometrics by e-mail at phann@fda.hhs.gov or by phone at 301-796-6640.

FDA Consumer website’s Advice for Patients.

Click here to view the original Notice and a complete listing of GDH-PQQ glucose testing strips.