The FDA is recalling Roche's ACCU-CHEK FlexLink Plus infusion set, a tool used to deliver insulin to diabetic patients.
The Class I recall is being issued because of the potential for under-delivery of insulin due to a tube (cannula) which may become kinked or bent when inserting the ACCU-CHEK FlexLink Plus infusion set. If this remains unnoticed, this can result in under-delivery or no delivery of insulin. This can lead to elevated blood glucose levels (hyperglycemia). Hyperglycemia can lead to many serious health complications including death.
This recall only applies to the ACCU-CHEK FlexLink Plus infusion sets that were launched in November 2010. ACCU-CHEK Ultraflex, other Accu-Chek infusion sets or insulin pumps are not affected by this recall and can be continued as directed by a physician or other qualified health care provider.
The company requested its customers to stop using the ACCU-CHEK FlexLink Plus infusion sets and return the unused products. Patients are to contact their health care providers or caregivers to determine if changes to their therapy are needed and how to temporarily continue insulin pump therapy without the ACCU-CHEK FlexLink Plus infusion set.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Nearly 26 million individuals are affected by diabetes in the United States each year, with about seven million people going undiagnosed. Diabetes is a chronic metabolic disease with no cure in which a person has high blood sugar because the body does not produce enough insulin (Type 1) or because cells do not respond to the insulin that is produced (Type 2). There are three main types of diabetes: Type 1, Type 2 and Gestational. Several groups of oral drugs, are effective for Type 2, such as Glucophage®, Glucotrol®, and Prandin®, among many others. The therapeutic combination in Type 2 may eventually include injected insulin as symptoms worsen. Along with the presence of physical symptoms, a common blood test known as the A1c can test for the disease.