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FDA Warning on Blood Glucose Meters

 

FDA Warns that Certain Blood Glucose Meters Can Prompt Excessive Insulin Administration

According to the FDA, diabetic patients who are also receiving therapeutic products that contain non-glucose sugars should not use blood glucose meters that take GDH-PQQ test strips.

These test strips contain glucose dehydrogenase pyrroloquinoline quinine, a chemical that reacts with non-glucose sugars such as maltrose, galactose and xylose found in peritoneal dialysis solutions and certain immunoglobulins.

Patients receiving these therapeutic products usually have very serious medical conditions, such as kidney failure or moderate to severe rheumatoid arthritis. These medications are usually administered in a hospital, either intravenously or through a peritoneal catheter.

If a patient’s blood sample contains any of these non-glucose sugars, the chemical reaction of GDH-PQQ and non-glucose sugars can falsely elevate glucose results. False high readings of blood glucose can lead to the patient receiving too much insulin, which could “potentially result in hypoglycemia, coma, or death”, said the FDA in a Public Health Notification released August 14, 2009.

Blood glucose meters that use the GDH-PQQ test strips are typically used in health care facilities. Instead of using the meters, facilities should instead use a laboratory assay to measure a patient’s blood glucose level if the patient is receiving an interfering product.

Products that use GDH-PQQ test strips include:

  • ACCU-CHEK® blood glucose meters
  • Abbott Freestyle meters
  • Home Diagnostics TRUEresult and TRUE2go meters
  • Smiths Medical – test strips used with the Deltec Cozmo Insulin Pump
  • Insulet – test strips used with the OmniPod Insulin Management System

It is important to note that this is NOT a recall of these products. The blood glucose meters listed above are safe, accurate and reliable for more than 99% of people with diabetes. GDH-PQQ meters and strips are okay to use if you are not using an interfering drug product or therapy.

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