Roche Response: FDA Test Strip Warning
August 13, 2009 (Roche Diabetes Care North America) - Recently, the U.S. Food and Drug Administration (FDA) issued a notice about potential errors with select blood glucose monitoring test strips that use technology known as GDH-PQQ, which include ACCU-CHEK® monitors as well as other monitors. The errors occur in a small number of diabetes patients who take certain drugs intravenously or by peritoneal catheter that may increase non-glucose sugars in the bloodstream. The presence of these non-glucose sugars may then result in falsely elevated blood glucose readings. The drugs and therapies available in the U.S. that cause the false readings are listed below:
- EXTRANEAL®
- Octagam® 5%
- WinRho® SDF Liquid
- Orencia®
- Adept® adhesion reduction solution
- HepaGam B®
- Bexxar®
It is important to know that this is not a recall of the ACCU-CHEK blood glucose monitors
The FDA notes that "GDH-PQQ meters and strips are okay to use if you are not using an interfering drug product or therapy" as listed above. For those who are using drugs that contain non-glucose sugars, the FDA recommends the following:
- Do not use GDH-PQQ glucose meters or test strips
- Use another type of glucose monitoring technology and continue to monitor your blood glucose as instructed by your healthcare provider
- Contact your healthcare provider if your results do not reflect the way you feel
Patient safety is important to Roche. ACCU-CHEK products have been proven to provide accurate and reliable results for patients with diabetes, when used as directed in package inserts.
Should you have any additional questions or concerns regarding ACCU-CHEK products, please call ACCU-CHEK Customer Care, available twenty four hours, seven days a week at 1-800-858-8072.
Andreas Stuhr, M.D.
Medical Director, North America
Roche Diabetes Care













Comments
FDA is working with
FDA is working with manufacturers to resolve the problems with GDH-PQQ glucose test strips, and is continuing to monitor adverse events associated with these products. You may be able to determine the type of glucose monitoring technology you are using by looking at the instructions that accompanied your meter or test strips, or at your meter’s box. The FDA released a list of test strips using the GDH-PQQ methodology that diabetics and healthcare professionals should avoid.
"blood glucose monitoring
"blood glucose monitoring test strips that use technology known as GDH-PQQ, which include ACCU-CHEK® monitors as well as other monitors. The errors occur in a small number of diabetes patients who take certain drugs intravenously or by peritoneal catheter that may increase non-glucose sugars in the bloodstream."
Ok, so if I'm taking some meds what test should I take? Or neither of them would be relevant?
Good job! THANKS! You guys
Good job! THANKS! You guys do a great website, and have some great contents. Keep up the good work.
Post new comment