Insulin pumps have most reported problems to FDA

Holbrook Mohr and Mitch Weiss
Associated Press

Destin, Florida – When Polly Varnado’s 9-year-old daughter was diagnosed with Type 1 diabetes, it didn’t take long for the family to hear about insulin pumps.

In September 2012, the girl picked out a purple one – her favorite color.

Over the next seven months, she proceeded to be hospitalized four times in a McComb, Mississippi medical center with high blood sugar. But when Varnado asked about all her daughter’s problems, she said, her doctor blamed user error.

“They said it wasn’t the insulin pump, it was my daughter,” said Varnado, who became a registered nurse so that she could better care for the girl.

When it comes to medical devices, none have had more reported problems over the last decade than insulin pumps, a product that’s used by hundreds of thousands of diabetics around the world, many of them children.

Collectively, insulin pumps and their components are responsible for the highest overall number of malfunction, injury and death reports in the U.S. Food and Drug Administration’s medical device database, according to an Associated Press analysis of reports since 2008.

In terms of injuries alone, insulin pumps were second only to metal hip replacements, whose problems with metal shavings in the body causing damage to bone and tissue and other issues, have been well-documented and widely reported.

By contrast, problems with insulin pumps largely have flown under the radar.

Medical device companies and many experts say insulin pumps are safe devices that can help diabetics lead more normal lives. They blame user error for most reported problems, noting that the pumps are complicated devices requiring special training for patients.

The FDA notes that “diabetes is a dangerous disease, and people with diabetes who rely on insulin are at higher risk.” The agency said it “has played a critical role helping to identify and address safety concerns for devices … including pushing manufacturers to improve the safety of their designs.”

Over the last decade, insulin pumps and pump parts made by Medtronic Inc. were subject to 20 manufacturer recalls and about 100 lawsuits alleging pump malfunctions, according to a joint investigation by the AP and the International Consortium of Investigative Journalists.

In a statement, Medtronic said it monitors the safety of its products through clinical trials and observational studies, and that “data supports both the safety and efficacy of our insulin pumps, which have helped hundreds of thousands of patients manage their diabetes.”

The company declined to answer more specific questions.

Varnado said she was unaware of problems with insulin pumps before receiving a notice in July 2013 that Medtronic was recalling some batches of parts for the model her daughter had used.

She reached a confidential settlement with the company in March 2017 after filing a federal lawsuit contending the device failed to properly deliver enough insulin. She remains convinced that the device harmed her child.

Dr. Ben Wheeler, a leading pediatric diabetes researcher in Australia, told the AP that the use of insulin pumps “appears safe” and is “potentially safer” than insulin injections, the traditional method of treatment.

Still, a 2015 study he co-authored found that 40 percent of insulin pump users experienced problems, “with a minority, particularly in children, requiring hospital management.” The study also said “it is noteworthy that overall pump failure rates do not appear to be improving with technological advances.”