In response to a June 2003 warning letter sent by the U.S. Food and Drug Administration (FDA), Roche Diagnostics Corporation has decided to halt shipment of its Disetronic Insulin Infusion Pump. During a nine-day on-site investigation of Disetronic Medical Systems AG in Burgdorf, Switzerland on January 27-February 5, 2003, the FDA found serious problems involving the manufacture of external insulin infusion pumps. Roche acquired Disetronic in May 2003.
The inspection revealed that the devices are adulterated within the meaning of section 501(h) of the Federal, Food, Drug, and Cosmetic Act, in that the methods used in, or the facilities or controls used for their manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice requirements of the Quality System regulation, as specified in Title 21, Code of Federal Regulation , Part 820.
See your doctor if you have suffered injuries due to a Disetronic Insulin Infusion Pump. In addition, it may be important to contact an attorney
who can help you protect your legal rights. Please keep in mind that there may be time limits
within which you must commence suit.
- Medical Devices & Implants