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Drug & Device News

By ALM Staff | Law Journal Newsletters |
September 29, 2009

Glucose Monitoring Methods May Not Work Well with Some Medical Products

The U.S. Food and Drug Administration (FDA) is advising health care providers that their patients should not use certain glucose monitoring methods if they are also receiving therapeutic products containing non-glucose sugars, such as peritoneal dialysis solutions and certain immunoglobulins. The glucose test strips causing concern are those containing glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ), including certain AccuCheck test strips, manufactured by Roche Diagnostics, and some Freestyle brand test strips, manufactured by Abbott Diabetes Care. These products can falsely elevate glucose results, which may prompt patients to use or to be administered too much insulin. 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. The affected products are listed at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm#attachment.

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