When Diabetes Devices Fail - ConsumerReports.org

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Take the Medtronic infusion set linked to Pamela’s death. 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. But in January 2016, when Pamela died following the insulin overdose, the problem had still not been corrected.

Further, 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. 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. 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.

When asked about these infusion sets and their subsequent recall, Medtronic told CR that it has “rigorous quality systems and reporting standards based on FDA and global regulatory requirements.” The company added that it investigates all reported problems and performs “a risk assessment to determine whether further action is appropriate.”

CR found other examples of both the FDA and manufacturers appearing to be slow to respond to reported problems.

For instance, there was a 57-year-old Texas man with type 1 diabetes who checked his blood sugar regularly using his OmniPod system, which consisted of an insulin pump, made by Insulet, and a FreeStyle glucose meter with test strips, both made by Abbott.

A lawsuit filed against Insulet and Abbott alleges that one day in March 2012, the man’s meter displayed inaccurate glucose readings, preventing him from keeping his actual glucose levels in check before he got into his car. Court documents state that while driving on a Dallas highway, he suffered from a “life-threatening blood glucose level” that “severely impaired his ability to safely operate his vehicle. As a result, [he] lost control of his vehicle, struck another vehicle, and was killed.”

It wasn’t until two years later that his wife received a recall notice from Abbott alerting users to immediately stop using the test strips and the glucose meters because they had the potential to cause erroneous blood glucose results.

They were not the only people allegedly harmed by the defective products while the FDA and manufacturers assessed the risk and investigated the potential hazard. In the two years between the man’s March 2012 death and the February 2014 recall, the MAUDE database shows that numerous adverse event reports were linked to these products, including emergency hospitalizations and at least one additional death.

When asked about the products and the recall, Abbott told CR that “the health and safety of our customers are our highest priority” and that the company’s quality control system “is regularly audited by the FDA.”

Another example of a devastating delay involves the diabetes device maker Dexcom. According to allegations in a lawsuit filed against the company, Dexcom knew of malfunctions and injuries connected to its G4 Platinum continuous glucose monitor as early as 2013, yet took more than two years to fix the problem.

The FDA knew about the problems as well. After conducting a government inspection of a Dexcom facility in November 2013, the FDA sent the company a warning letter in March 2014 citing several issues concerning its G4 monitor. The letter also cited the company’s failures to adequately report adverse events tied to the device. The FDA specified, in part, that Dexcom’s “procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to [medical device reporting] requirements.”

Despite this official warning, it took until February 2016 for Dexcom to issue a recall of the G4 monitor, which could fail to audibly alert users of blood glucose highs and lows, and “could result in serious adverse consequences, including death.” Dexcom’s sluggish response had tragic repercussions: In the year after the FDA sent the warning letter, there were at least 10 deaths and 409 serious injuries reported to MAUDE concerning the G4 monitor.

One accident that took place in that time frame involved a North Carolina man who, in August 2015, wasn't alerted by his Dexcom G4 monitor that his blood sugar was low, according to the aforementioned lawsuit against the company. He “passed out while driving after suffering a dangerously low blood sugar,” court documents state. The man totaled his car and suffered injuries.

When asked about the lawsuit, the warning letter, and the product recall, Dexcom declined to comment.

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