Warning on GDH-PQQ & GDO Blood Glucose Test Strips

The Institute for Safe Medication Practices (ISMP) is warning diabetic patients about potentially fatal glucose monitoring errors in patients receiving products that contain other sugars. These include parenterals that contain maltose or galactose, oral xylose, and peritoneal dialysis solutions that contain icodextrin.

Some glucose meters use test strips that do not distinguish between glucose and the other sugars found in products mention above. In such cases, the reading may show blood sugar levels that include both the patients’ actual blood glucose levels as well as the other types of sugars that the diabetic patient has received.

A falsely elevated blood glucose reading could cause over-use of insulin by the patient, which could result in hypoglycemic shock and even death.

The FDA has received dozens of reports of hypoglycemic events associated with peritoneal dialysis solutions containing icodextrin, such as Extraneal. In one of the reported cases, a 62 year-old hospitalized dialysis patient on Extraneal therapy died from severe hypoglycemia because his treatment was based on falsely elevated glucose readings from an inappropriate meter. This occurred despite glucose readings from the hospital lab that were strikingly lower than those produced by the meter.

Test strips that cannot distinguish between glucose and other sugars contain reagents called GDH-PQQ or GDO. Other types of meters use reagents that are capable of distinguishing glucose from the other sugars. These reagents are called GDH-NAD, GDH-FAD, glucose oxidase and glucose hexokinase. It is important to check the package insert that comes with the test strips to determine which type of reagent they contain.

Patients should consider using only glucose meters that use test strips with the ability to distinguish between glucose and other sugars.

NOTE: This is just a warning. It is not a recall.

Additional Information:

ISMP Medication Safety Alert! FDA Advise-ERR: Prevent dangerous drug-device interaction causing falsely elevated glucose levels. June 19, 2008.

FDA Drug Safety Newsletter. Icodextrin (marketed as EXTRANEAL) and Point-of-Care Glucose Monitoring. Volume 1, Number 4. Summer 2008.

FDA Center for Biologics Evaluation and Research. Fatal Iatrogenic Hypoglycemia: Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product. April 17, 2008.

FDA MedWatch Safety Alert – Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products. 2005.