When some medical devices fail, they can cause serious, painful, life-altering injuries. When other medical devices fail, they can kill you.
Diabetes devices are one example of this type of device. These products, which include insulin pumps and blood glucose monitors, are the subject of a report published by Consumer Reports (CR) on December 8, 2020.
CR’s report begins with the story of a 64-year-old woman who fell into a coma and died one week after her husband refilled her insulin pump’s reservoir with insulin. He also changed the pump’s infusion set, a plastic tube assembly that connects the patient to the reservoir.
In the span of 18 hours, the insulin pump had incorrectly administered five to six days’ worth of insulin.
Medtronic Knew About the Device’s Risks
According to CR, Medtronic, the maker of the infusion set that allegedly caused this patient’s death, knew about the dangers its device presents. In the span of 11 months (June 2013-May 2014), the manufacturer received 750 complaints about the infusion sets.
The patient in CR’s account died of her insulin overdose over 18 months later—with the device not having been fixed.
The deceased’s husband filed a lawsuit against Medtronic. In it, he points out that the U.S. Food and Drug Administration did not clear the company’s infusion set for redesign until August 2016. Medtronic waited until its stock of allegedly defective infusion sets ran out before commencing with the manufacturing of the redesigned infusion sets, which found their way to market in April 2017, the lawsuit alleges.
In September 2017, the FDA announced that Medtronic had recalled the devices manufactured prior to redesign. Within the scope of this recall, the company finally informed the public they should no longer use previous models of the infusion set.
According to Medtronic’s announcement of the recall, the vent membrane, a component in the recalled infusion set, can get wet and block the vents, thereby releasing an excessive dose of insulin, which can cause hypoglycemia. Interestingly, the chief medical officer of Medtronic’s diabetes group stated that the flaw had not caused any deaths to date, according to Bloomberg’s coverage of the recall.
Other Allegedly Defective Diabetes Medical Devices
A Texas man with type 1 diabetes got an inaccurate glucose reading from his FreeStyle glucose meter and as a result, failed to maintain his glucose levels before driving. His glucose-level dropped while he was driving, impairing his driving ability. The man crashed into another vehicle on the road and died.
Two years after the accident, the man’s wife received a notice from Abbot, the FreeStyle glucose meter manufacturer, warning the product could deliver false glucose readings, and use of the device should immediately cease.
Multiple other adverse events, including one death, were reported during the two-year lapse between the Texas man’s death and the recall of the FreeStyle device.
In yet another instance of defective diabetes medical devices, manufacturer Dexcom was allegedly aware of its occasional failure to alert patients when their glucose levels were too high or too low. The FDA warned Dexcom about problems with its G4 Platinum continuous glucose monitor in November 2013, but the device was not recalled until March 2014.
CR offers in its report a bit of comfort by explaining how the FDA uses interconnected technologies to track the performance of important medical devices. Diabetes patients might also consider taking some steps to protect themselves from potentially defective monitoring devices, insulin pumps, etc. They recommend that users evaluate pumps and other devices thoroughly before buying them and that they remain aware of inconsistencies with glucose meters.