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U.S. Department of Health and Human Services

Medical Devices

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FDA Posts Notice On GDH-PQQ Glucose Test Systems

Source: FDA's Alerts and Notices for Medical Devices, August 13, 2009

FDA has released a public health notification to alert healthcare practitioners to 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. The notification provides background information on this problem, a summary of fatality reports FDA has received, and recommendations to reduce the risk. This problem can occur wherever these products are used including in-patient and out-patient healthcare facilities, and at home.

Additionally, an Advice for Patients on this subject can be found on the FDA Consumer website.