According to an online news story posted on startribune.com, the U.S. Food and Drug Administration (FDA) recognizes Medtronic is slow to update and recall its defective insulin pumps for diabetes patients. The FDA states that the company is currently working on correcting issues concerning its diabetes business, but the company took too long to respond, and the measures are not enough.
The report states that Medtronic took over three years to start recalling its insulin pumps that have defective retainer rings after the company first became cognizant of the issue. These complaints from the FDA were released in a warning letter the FDA sent to Medtronic back in December. The FDA’s letter has recently become public.
The FDA letter to Medtronic also states that the company failed to investigate over 800 complaints about the defective, updated retainer rings. These complaints came from diabetes patients who were using defective insulin pumps. Medtronic allegedly also failed to quickly notify the FDA after discovering the issue with their insulin pump devices and that the pumps could cause serious injury or death.
According to the FDA’s letter, the FDA accuses Medtronic of still not conducting effectiveness checks to make certain that the updated procedures and mandated employee training will stop the reoccurrence of the specified deficiencies.
Medtronic did not debate the details provided in the FDA’s warning letter. However, Medtronics argued that they are making the necessary improvements. A Medtronic spokeswoman, Pamela Reese, stated that Medtronics takes the issues very seriously and will hold itself to the “highest standards of quality and patient safety.”
Although FDA warning letters are fairly common, Dr. Michael Carome, a safety expert quoted in the news article, stated that this Medtronic letter “raises very serious concerns.” He also stated that the FDA warning showed a “very high level of serious, severe violations by Medtronic.” Dr. Michael Carome, director of the Washington D.C.-based Public Citizen, said that Medtronic’s violations may have put “patients at risk for potential serious harm.”
The FDA’s letter stated that its investigation of Medtronic began as an internal investigation in June 2016. the investigation was prompted after the agency received several complaints about the defective clear retainer rings in Medtronic’s MiniMed 600 series insulin pumps. The initial plan to warn customers of the issue in 2016 was abandoned.
The FDA also accuses Medtronic of failing to introduce its redesigned black retainer rings until August 2019, and the company did not start informing customers of the retainer ring failures until November 2019. The FDA’s letter also claims that Medtronic did not adequately assess the serious risk of medical device failures to its users.
According to the FDA, there was a reasonable chance that using the insulin pumps with the clear retainer ring could cause severe adverse health issues, such as hypoglycemia. Hypoglycemia can cause seizures, a loss of consciousness, severe hyperglycemia, and death.
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