FDA Issues Public Health Notification on Glucose Monitoring Technology

FDA NOTE TO CORRESPONDENTS
For Immediate Release: Aug. 14, 2009

Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Issues Public Health Notification on Glucose Monitoring Technology
The U.S. Food and Drug Administration (FDA) today advised health care practitioners and patients against using certain glucose monitoring technology that employs a specific test strip when the patients are also receiving therapeutic products containing non-glucose sugars.

Non-glucose sugars contained in some therapeutic products such as peritoneal dialysis solutions and certain immunoglobulins can falsely elevate glucose results, which may prompt excessive insulin administration. These therapeutic products, which are labeled to indicate that they may interfere with this particular glucose monitoring technology, are mostly used in patients with serious medical conditions, including kidney failure and moderate to severe rheumatoid arthritis.

In a Public Health Notification and an accompanying Advice for Patients, the FDA listed the manufacturers and brands of glucose test strips that contain glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ)—the chemical that reacts with the non-glucose sugars (maltose, galactose and xylose) contained in some therapeutic products that produce a falsely high test result,

Most GDH-PQQ devices are used in health care facilities, which should instead use a laboratory assay to measure a patient's glucose if the patient is also receiving an interfering product. The FDA also makes recommendations to minimize the risk of potential shortages of these products until health care facilities can obtain non-GDH-PQQ strips and meters.

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

FDA Advice for Patients: Serious Errors with Certain Blood Glucose Meters and Strips:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm177189.htm