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FDA Sends Warning Letter to Medtronic About Diabetes Business
The warning letter focused on the inadequacy of the requirements in risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events.
FDA recently sent a warning letter to Medtronic for the headquarters facility of its diabetes business in Northridge, California.
The warning letter focused on the inadequacy of specific medical device quality system requirements at the Northridge facility in risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events.
The letter is part of the FDA’s response to past recalls of Medtronic’s MiniMed 600 series insulin infusion pump and remote controller device for MiniMed 508 and Paradigm pumps for diabetes patients.
In October, Medtronic expanded two recalls on both MiniMed devices due to potential cybersecurity risks. FDA identified both of these as Class I recalls, the most serious type of recall.
The agency urged patients using the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps with a remote controller, part of the expanded recall, to follow FDA’s guidance on next steps.
“We are committed to fully resolving all observations as effectively and quickly as possible. Nothing is more important to us than providing the highest quality products to people living with diabetes,” Sean Salmon, executive vice president and president of the diabetes business at Medtronic, said in the recent announcement.
About 1.5 Americans are diagnosed with diabetes every year. And type 2 diabetes is the most common type, accounting for nearly 90 to 95 percent of all diabetes cases.
As part of the recent warning letter, Medtronic will apply resources from across the company and utilize external experts to ensure the most effective response.
Additionally, the company will implement various corrective actions and process improvements related to the observations and continue reviewing these actions with the FDA. But Medtronic is not requiring any action for patients or their healthcare providers at this time.
“Every dayEveryday millions of people living with diabetes around the world rely on the innovations we deliver, and Medtronic remains deeply committed to ensuring their safety and well-being,” Salmon concluded.
