The latest warning letter asks Medtronic to update its systems and procedures in order to deliver safe and high-quality devices to consumers.
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The U.S. Food and Drug Administration issued a warning letter to American-Irish medical device company Medtronic after flagging certain inadequacies in its facility in Northridge, California.
Medtronic revealed that the December 9 FDA letter focused on specific medical device quality systems requirements that the regulator found inadequate in terms of risk assessment, complaint handling, corrective and preventive actions, adverse event reporting, and device recalls. The FDA inspected the facility in July, which led to the recall of Medtronic’s MiniMed 600 series insulin infusion pump and MiniMed 508 and Paradigm pump remote controllers in October.
Back then, the FDA ordered the withdrawal of the products Model 630G and Model 670G insulin pumps to replace units that were designed with a clear retainer ring with ones that have a black retainer ring. The ring is necessary to lock the insulin cartridge into place in the pump’s reservoir. If locked incorrectly or using the wrong material, over or under-delivery of insulin may happen.
The latest warning letter asks Medtronic to update its systems and procedures in order to deliver safe and high-quality devices to consumers.
“Every day 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. We are committed to fully resolving all observations as effectively and quickly as possible,” noted executive vice president and president of the Diabetes arm Sean Salmon in a statement. “Nothing is more important to us than providing the highest quality products to people living with diabetes.”
Medtronic said that there’s no need for patients or their healthcare providers to take any action in relation to the letter. It also said that it will seek the help of external experts and tap into its internal expertise to make the necessary corrections and process improvements that the FDA pointed out.
This is not the first time that Medtronic has crossed the FDA this year. In June, the regulator told health care providers to stop using Medtronic’s Heartwave Ventrical Assist Device (HVAD) system for end-stage heart failure patients, citing neurological risks and high frequency of mortality. The regulator had also received complaints that the device had either experienced pumping delays or did not restart.
In response, Medtronic had said that although it will comply with the stop order, patients who have already started using the device would need to keep doing so for years and that the company will continue to provide product support for existing users, caregivers, physicians, and VAD coordinators.
