While the U.S. Food and Drug Administration acknowledges Medtronic is actively working on fixing issues within its diabetes business, especially in regard to some of its insulin pumps, it says the steps took too long and are not enough.
Medtech giant Medtronic took more than three years to replace and start recalling insulin pumps with defective retainer rings after first becoming aware of the problem, according to an FDA warning letter sent to the company in December and recently made public.
The company also failed to investigate more than 800 complaints about defective updated retainer rings from diabetes patients who were using the product. It also failed to promptly notify the FDA within 30 days after discovering that issues with the device could lead to serious injury or death.
“In summary, your corrective actions are still in process, and you have not yet conducted effectiveness checks to ensure the updated procedures and required employee training will prevent reoccurrence of the identified deficiencies,” the FDA said in the letter.
The company did not dispute any details in the FDA’s warning letter but made the case that it is making necessary improvements in its diabetes business.