GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) Glucose Monitoring Technology
MedSun: Newsletter #40, September 2009

FDA MedWatch Safety Alert

FDA 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. The FDA Public Health Notification provides a list of GDH-PQQ Glucose Test Strips and recommends that healthcare practitioners avoid using GDH-PQQ glucose test strips in healthcare facilities or take steps to never use them on patients receiving interfering substances.

Additional Information:

FDA MedWatch Safety Alert. GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) Glucose Monitoring Technology. August 13, 2009.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm177295.htm

FDA Public Health Notification. FDA Public Health Notification: Potentially Fatal Errors with GDH-PQQ* Glucose Monitoring Technology. August 13, 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm

Advice for Patients: Serious Errors with Certain Blood Glucose Monitoring Test Strips. August 13, 2009.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm177189.htm


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