FDA Warning For Some Diabetic Testing Strips

Jamie Sheller

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Recently, the FDA issued a warning regarding the use of certain types of glucose testing strips. According to the FDA, some of the strips can't distinguish between maltose, xylose, galactose, and other sugars. Such problems can produce falsely high readings, leading to dangerous overdoses of insulin. High doses of insulin can cause severe injury or death. Due to these dangers, the FDA warns that patients using therapies that include nonglucose sugars should not use GDH-PQQ glucose test strips. Dialysis patients or those with recent surgeries are more likely to use therapies that contain nonglucose sugars.

From 1997-2009, 13 deaths associated with false results in GDH-PQQ test strips were reported to the FDA. Those reports came from healthcare facilities, and prior to death, the patients suffered hypoglycemia, neurologic deterioration, severe hypoxia, and coma. The FDA safety alert included the following types of testing strips: ACCU-CHEK Comfort Curve test strips, ACCU-CHEK Aviva test strips, ACCU-CHEK Compact test strips, ACCU-CHEK Go test strips, ACCU-CHEK Active Freestyle test strips, Freestyle test strips, TRUEtest test strips, and Abbot Diabetes Care Freestyle test strips.