FDA Formally Warns Medtronic, Claiming Improper Diabetes Facility Quality Requirements

FDA Formally Warns Medtronic, Claiming Improper Diabetes Facility Quality Requirements

Following a July 2021 inspection, the US Food and Drug Administration (FDA) sent a December 9th warning to medical technology company Medtronic for lacking proper quality requirements at its Diabetes Business located in Northridge, CA. 

The warning is related to the company’s recalled Minimed Insulin Pump. The insulin pump and accessory devices were approved by the FDA in 2017 but were recalled for quality issues that led to approximately 2,000 injuries and 26,000 error reports. 

Although the company says it is committed to improving its facilities and production, Medtronic suffered a 7% drop in stock price as a result of the news. 

The 600 series MiniMed insulin pumps were recalled due to a missing or broken retainer ring, which helps to lock the insulin cartridge in place in the pump’s reservoir compartment, according to the FDA. The recall affects all 630G (MMT-1715) models as well as all 670G (MMT-1780) models.

Based on research findings and adverse events reports, there are several injuries and complications associated with the MiniMed Insulin Pump that are not listed on the warning label. These injuries and complications include hypoglycemia, seizures, diabetic coma, and even death. 

The FDA classified the action as a Class I recall, the most serious kind of recall for medical devices, meaning that using the device could result in serious injuries or death. 

MiniMed Pumps have a long history of defects and recalls over the last decade. Prior Medtronic MiniMed insulin pump recalls date back as far as 2009. Another Medtronic recall involved a remote controller for insulin pumps that contained potential cybersecurity risks; an unauthorized person could gain access to the remote control and either stop insulin delivery or over-deliver insulin to users. 

Center for Devices and Radiological Health. “Medtronic Recalls Minimed Insulin Pumps.” U.S. Food and Drug Administration, FDA, https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-minimed-insulin-pumps-incorrect-insulin-dosing.

Center for Devices and Radiological Health. “Medtronic Recalls Remote Controllers for Certain Minimed Insulin Pumps.” U.S. Food and Drug Administration, FDA, https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-remote-controllers-used-paradigm-and-508-minimed-insulin-pumps-potential.

Manfredi, Lucas. “Medtronic Shares Slide after Diabetes Business Receives FDA Warning Letter.” Fox Business, Fox Business, 15 Dec. 2021, https://www.foxbusiness.com/markets/medtronic-shares-slide-fda-warning.

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