Medtronic receives FDA warning letter over quality control issues at diabetes HQ

Medtronic is scrambling to address a host of quality control concerns raised by the FDA in a warning letter that followed an inspection of its Northridge, California, facility.

The Dec. 9 letter highlights shortfalls in risk assessment, corrective and preventive action, complaint handling, device recalls and adverse event reporting at the Los Angeles-area space, which serves as the headquarters of Medtronic’s diabetes segment.

In response, Medtronic said that it plans to call in external experts and tap resources from all across the company to deploy process improvements and corrective actions to address the identified issues—all with the continued oversight of the FDA.

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“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,” said Sean Salmon, executive vice president at Medtronic and president of the diabetes business.

“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,” Salmon said.

Despite the inadequacies flagged in the Northridge facility’s medical device quality system requirements, as it begins to rectify those issues, Medtronic said there’s no need for patients and healthcare providers using the company’s diabetes devices to take any protective action.

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The warning letter was the result of an inspection of the Southern California facility that the FDA completed in July. The inspection, in turn, was related to a pair of Class I recalls issued for several models of Medtronic’s MiniMed insulin pumps.

The first of the recalls began in August 2018, when the company identified a cybersecurity risk associated with the optional remote controller that can be used with the MiniMed 508 or MiniMed Paradigm pumps. A flaw in the technology means that an unauthorized person could hack into the connection between the controller and the pump and tweak its insulin delivery.

The second—and much larger—recall was initiated in November 2019, sparked by an issue with the 600 series of the pumps in which a plastic retainer ring designed to lock the insulin reservoir into the pump can become loose or damaged if the pump is dropped or bumped. If not secured in place, the reservoir may be positioned incorrectly, potentially dispensing either too large or too small of a dose of insulin.

In October of this year, both of the recalls were expanded to include all affected devices, regardless of the original parameters of damage and warranty status. That brought the total number of recalled devices to nearly 500,000, including 31,310 remote controllers and 463,464 MiniMed 600 pumps—though Medtronic noted at the time that it had already replaced almost half of the affected pumps since the 2019 recall began.