The FDA flagged several product safety problems in a December warning letter to Medtronic's diabetes group, citing the medical device maker for not appropriately classifying patient risks for faulty MiniMed insulin pump devices and for not initiating a recall despite tens of thousands of medical device reports made to the agency over three years.
Medtronic classified the patient risks due to faulty MiniMed 600 series insulin devices lower than was "appropriate," failed to adequately investigate, review and evaluate customer complaints regarding the possible failure of devices, as well as failed to notify the FDA within 30 days of identifying or becoming aware of patient safety risks with devices, according to FDA's letter. The agency was also critical of how an eventual recall of MiniMed pumps was managed.
The warning letter was dated Dec. 9 and publicly acknowledged by Medtronic Dec. 15. However, FDA did not make a copy of the letter public until Dec. 28.
Key problems identified by the FDA involve how Medtronic assessed the risk of faulty MiniMed 600 Series pumps for patients and how the company handled customer reports of device malfunctions. Faulty retainer rings were found in certain MiniMed 600 series pumps, which could potentially cause the under- or over-dosing of insulin.
Among the agency's critiques was that Medtronic "did not identify the actions needed to control devices already in distribution" after manufacturing issues were identified.
Medtronic initiated corrective and preventative actions in June 2016 after customer complaints increased, according to the letter. However, a recall was not initiated until November 2019 after the company "received over 74,000 retainer ring complaints, with over 57,000 of those reported to FDA as [medical device reports]."
The medtech giant did not originally pull devices from the market because they determined that "the risk of serious adverse health consequences was 'improbable,'" according to the FDA. But the agency disagreed with Medtronic's assessment.
"As previously discussed, your firm's justification in June 2016 for not initiating a recall was based on your firm's underestimated risk calculation," the agency said.
A recall was eventually initiated in 2019 for MiniMed 600 Series pumps, ultimately impacting over 463,000 devices in the U.S.
The warning letter was issued following a facility inspection of Medtronic's diabetes group headquarters in Northridge, California, which took place from June to July. The inspection was due to past recalls for MiniMed 600 series insulin pumps and remote controllers for MiniMed 508 and Paradigm pumps.
In 2018, Medtronic recalled remote controllers for MiniMed 508 and Paradigm pumps due to cybersecurity risks, and in 2019, the company initiated the MiniMed 600 series pumps recall.
Both recalls were labeled Class I by the FDA due to the risk of serious injury or death, and both recalls were expanded last October.
The December warning letter is the latest setback for Medtronic's diabetes group, which has struggled to stay at the 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 higher 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, J.P. Morgan analysts wrote that it was another blow for a diabetes segment that "was already falling meaningfully behind the competition and suffering heavy patient turnover with a non-competitive [continuous glucose monitor] and a delayed launch of its hybrid closed-loop pump to compete with Tandem's Control-IQ, this will only exacerbate the problem."
One lingering question is whether the warning letter will delay the review of Medtronic's MiniMed 780G pump, which could cause the company to fall further behind.
Medtronic's stock price dropped over 11% to $99.53 in the days following the news of the warning letter, but the stock has since rebounded to $106.39 when the market closed Tuesday.
Medtronic said in an emailed statement that the company is committed to addressing the FDA's observations from the inspection and the warning letter.
"At the time of the warning letter, we were already in the process of implementing a range of corrective actions related to each of the observations cited during the July inspection as part of a comprehensive plan to address the underlying causes of the inspection observations and make systemic changes," Medtronic said.
Even after Medtronic initiated its recall of MiniMed 600 series pumps, the FDA was critical of the company's actions. According to the letter, Medtronic failed to implement changes to its processes that would have prevented future malfunctions. For example, Medtronic advised customers during the recall to contact the company only if a retainer ring was damaged rather than all customers with devices that had the faulty retainer rings installed.
"Thus, after redesigning the retainer ring to prevent further risk, you failed to adequately remove the pumps containing the older, less robust ring from the market," the FDA stated.
The agency was also critical of how Medtronic handled the review and eventual recall of MiniMed 508 and Paradigm controllers.
While the FDA acknowledged that Medtronic is working to address the issues, the agency said that more work needs to be done. According to the letter, after Medtronic's Nov. 5 update to the FDA, there were still 38 corrective and preventative actions that required "remediation and/or clarification" and 14 corrective and preventative actions "requiring a new complaint monitoring plan."
"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 letter stated.