![]() ![]() It was the September 2017 recall that ultimately instructed consumers to stop using the older models, including the one Pamela used the night of her death. And though the new, safer infusion sets became available in April 2017, it wasn't until that September-more than four years after the hazard was identified-that Medtronic recalled all infusion sets made before the redesign. But in January 2016, when Pamela died following the insulin overdose, the problem had still not been corrected.įurther, the lawsuit alleges that it took Medtronic until August 2016 to obtain FDA clearance for a redesign, and that it didn’t start manufacturing the redesigned products until January 2017, after the stock of the older infusion sets were depleted. ![]() Between June 2013 and May 2014, Medtronic received 750 complaints related to the same infusion sets, according to a deposition referenced in the Arkansas family’s lawsuit. Take the Medtronic infusion set linked to Pamela’s death. We’re tracking people who die or almost die because of inaccurate devices.” “We’re not tracking device stability and accuracy. “The system is not set up to manage the reporting of all the issues and problems,” says Anna McCollister, a health technology consultant who is a member of two FDA diabetes advisory committees. And CR found that reports to the database can languish for years without being fully addressed by the government or manufacturers. But it's notoriously unwieldy to navigate and has many inconsistencies. MAUDE, which is meant to alert the FDA and manufacturers to potential red flags, offers valuable information. “It’s so easy, when you’re using more than one device, to blame the other device, or to blame the user.”Īdverse event reports, which can be made by consumers, healthcare providers, or manufacturers, can’t on their own prove that a device caused an injury or a death. “It’s not as simple to isolate the problematic device when you’ve got moving parts with insulin, and glucose test strips, and an infusion set,” Kinard says. And they’re all used to manage an already complicated disease that requires constant user involvement. Instead, what emerged from the sea of product codes was evidence that each diabetes device has its own design intricacies and potential for error, which is then compounded by the fact that they're typically used in conjunction with several other diabetes devices. We found that from January 2019 to July 2020, almost 400 deaths and 66,000 injuries were linked to commonly used diabetes devices, such as glucose monitors, glucose test strips, insulin pumps, and infusion sets.ĭiabetes devices from multiple manufacturers, including Abbott Laboratories, Dexcom, Medtronic, and Tandem Diabetes Care, were cited in the reports, but no one product stood out. To assess what may be driving the high number of adverse events connected to diabetes devices, CR analyzed recent reports submitted to MAUDE, using Device Events. In fact, diabetes devices account for more adverse event reports-including malfunctions, injuries, and deaths-than any other category of medical device submitted to the FDA, according to a Consumer Reports investigation. Although diabetes devices, which are used by people with type 1 and type 2 diabetes, have advanced substantially over the past 10 to 15 years and made it easier for them to control their blood sugar, design flaws and malfunctions can have deadly consequences. Medtronic also didn't comment on the case but told CR that “patient safety is highest priority.” ![]() Kevin Haverty, a partner at the law firm Williams Cedar in Philadelphia who represented Gary, says the case was resolved out of court in 2018, but he couldn't provide details. In an internal memo in July 2013, the FDA concluded that it wasn't needed because Medtronic “appears to have properly informed the public.” And the Food and Drug Administration, which regulates medical devices, issued no public statement to follow up on Medtronic’s letter. But the lawsuit claims that Medtronic didn't notify Pamela of that possibility when she bought her device. ![]()
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