The FDA reported several product safety concerns in a December warning letter to the diabetes group Medtronic, citing the medical device maker. for failing to properly classify the risks to patients for faulty MiniMed insulin pump devices and for failing to initiate a recall despite tens of thousands of medical device reports submitted to the agency over three years.

Medtronic graded patient risk from defective MiniMed 600 series insulin devices below “appropriate”, failed to adequately investigate, review and assess complaints customers regarding the possible device failure, as well as failing to notify the FDA within 30 days of identification. or become aware of the risks to patient safety with the devices, according to the letter from the FDA. The agency also criticized the way a possible MiniMed pump recall was handled.

The warning letter was dated December 9 and publicly acknowledged by Medtronic on December 15. However, the FDA did not release a copy of the letter until December 28.

The key issues identified by the FDA relate to how Medtronic has assessed the risk of MiniMed 600 Series Pumps for Patients and How the Company Handled Customer Reports of Device Malfunctions. Defective retaining rings have been found in some MiniMed 600 series pumps, which could potentially cause the insulin underdose or overdose.

Among the agency’s criticisms were that Medtronic “did not identify the actions needed to control devices already in distribution” after manufacturing issues were identified.

Medtronic initiated corrective and preventive actions in June 2016 after the increase in customer complaints, according to the letter. However, a recall was not launched until November 2019 after the company “received more than 74,000 retaining ring complaints, of which more than 57,000 were reported to the FDA as [medical device reports]. “

The medical technology giant did not initially withdraw the devices from the market because they determined that “the risk of serious adverse health consequences was ‘unlikely’,” according to the FDA. But the agency disagreed with Medtronic’s assessment.

“As previously stated, your company’s rationale in June 2016 for not initiating a recall was based on calculating your company’s underestimated risk,” the agency said.

A recall was finally launched in 2019 for the MiniMed 600 series pumps, ultimately affecting more than 463,000 devices in the United States.

The warning letter was issued following an inspection of the installation of Medtronic Diabetes Group Headquarters in Northridge, Calif., which ran from June to July. The inspection was due to previous recalls of MiniMed 600 series insulin pumps and remote controls for the MiniMed 508 and Paradigm pumps.

In 2018, Medtronic recalled the MiniMed 508 and Paradigm pump remotes due to cybersecurity risks, and in 2019, the company initiated the recall of the MiniMed 600 series pumps.

Both recalls were labeled Class I by the FDA due to the risk of serious injury or death, and both recalls were extended last October.

The December warning letter is the latest setback for Medtronic’s diabetes group, which has struggled to stay on top of a rapidly growing diabetes technology market. More people are using insulin pumps and continuous glucose monitors, and companies like Dexcom, Abbott Laboratories, Insulet and Tandem Diabetes Care have all benefited from the increased demand.

However, Medtronic has not capitalized on this growth, and experts believe the company will continue to lose ground as new products from Dexcom, Abbott and Insulet are launched or expanded.

When Medtronic announced the warning letter last month, JP Morgan analysts wrote that this was yet another blow to a diabetes segment that “was already significantly behind the competition and suffering from high patient turnover with a [continuous glucose monitor] and a delayed launch of its closed-loop hybrid pump to compete with Tandem’s Control-IQ, that will only exacerbate the problem. “

A lingering question is whether the warning letter will delay the review of Medtronic’s MiniMed 780G pump, which could cause the company to further delay.

Medtronic’s stock price fell more than 11% to $ 99.53 in the days following news of the warning letter, but the stock has since rebounded to $ 106.39 at the close of Tuesday market.

Medtronic said in an emailed statement that the company is committed to responding to FDA comments arising from the inspection and the warning letter.

“At the time of the warning letter, we were already implementing a series of corrective actions related to each of the observations cited during the July inspection as part of an overall plan to address the causes. underlying inspection observations and making systemic changes, ”Medtronic said.

Even after Medtronic launched its recall of the MiniMed 600 series pumps, the FDA criticized the company’s actions. According to the letter, Medtronic failed to implement changes in its processes that would have prevented future malfunctions. For example, Medtronic advised customers during the recall to contact the company only if a retaining ring was damaged rather than all customers with devices with the faulty retaining rings installed.

“So after redesigning the retaining ring to avoid any additional risk, you have failed to adequately remove the pumps containing the older, less rugged ring from the market,” the FDA said.

The agency also criticized the way in which Medtronic handled the review and possible recall of the MiniMed 508 and Paradigm controllers.

While the FDA acknowledged that Medtronic was working to resolve the issues, the agency said there was still work to be done. According to the letter, after Medtronic’s Nov. 5 update to the FDA, there were still 38 corrective and preventive actions that required “correction and / or clarification” and 14 corrective and preventive actions “requiring a new plan to resolve. monitoring complaints “.

“In summary, your corrective actions are still ongoing and you have not yet performed effectiveness checks to ensure that updated procedures and required employee training will prevent the recurrence of identified deficiencies,” the letter reads. from the FDA.