Important Safety Information: Glucose Monitoring and Interfering Substances
Important Safety Information: Glucose Monitoring and Interfering
Substances
Last Updated: Friday, August 17, 2009
At Abbott Diabetes Care patient and product safety is our top priority. Abbott recognizes the concerns raised by the recent FDA Public Health Notice regarding glucose monitoring and interfering substances and supports the FDA's efforts to inform health care providers and patients about this important issue.
Abbott has two glucose monitoring technologies. Abbott's Precision blood glucose monitoring systems do not use GDH-PQQ enzyme technology. Precision systems use GDH-NAD enzyme technology designed to minimize interferences from common non-glucose sugars. Precision systems are used by patients and professionals across the United States and in over 1,400 U.S. hospitals.
Abbott's second glucose monitoring technology is the FreeStyle brand of blood glucose monitoring systems. The FreeStyle brands of blood glucose monitoring systems do currently use GDH-PQQ technology. As a result, and as is indicated in our product labeling and as is pointed out by the FDA's Public Health Notification, GDH-PQQ test strips should not be used with or by patients who receive interfering products which include:
- Extraneal (icodextrin) peritoneal dialysis solution
- Some Immunoglobulins including Octagon 5% Gamimune N 5%, WinRho SDF Liquid, Vaccinia Immune Globulin Intravenous (Human), HepaGamB
- Orencia (abatacept)
- Adept adhesion reduction solution (4% icodextrin)
- BEXXAR radioimmunotherapy agent
- Any product containing, or metabolized into Maltose, Galactose or Xylose.
If you are a health care provider or person with diabetes and have questions about Abbott's glucose monitoring products and interfering substances, we encourage you to call our Customer Service center at (888) 522-5226. Our customer care representatives are available 24 hours a day 7 days a week to help you with your question and concerns.
Helpful Links
- U.S. Food and Drug Administration (FDA)
www.fda.gov - Glucose Safety (Baxter)
www.glucosesafety.com
DOC20154-Rev-A 08/09
