Insulin Pump Injuries & Malfunctions Lead in FDA Adverse Event Reports

Published on March 23, 2020 by Sandy Liebhard

When it comes to medical devices, none appear more dangerous than insulin pumps.

In fact, according to a recent Associated Press analysis of adverse events logged with U.S. Food & Drug Administration’s (FDA) medical device database since 2008, insulin pumps had the highest overall number of reports involving injury, death, or malfunction.

Only Metal Hips Had More Injury Reports

In regards to injuries, the electronic devices were second only to metal hip implants. But while the issues surrounding defective metal-on-metal hips have been widely publicized over the past several years, those associated with insulin pumps have, for the most part, been able to fly under the radar.

Insulin pumps deliver a controlled dose of insulin to adults and children who suffer from Type 1 diabetes, removing the need for self-administered injections. Manufactures contend that these products are safe and assert that most injuries result from user error.

But one 2015 study found that 40% of insulin pump users experienced problems, “with a minority, particularly in children, requiring hospital management.”  The authors of the paper also noted that “overall pump failure rates do not appear to be improving with technological advances.”

Medtronic MiniMed Insulin Pump Recall

According to the Associated Press, pumps marketed by a single manufacturer – Medtronic, Inc. – have been the subject of 20 recalls and more than 100 insulin pump lawsuits alleging device malfunctions over the last decade.

The company announced its most recent recall only last November. That action affected more than 322,000 Model 630G and Model 670G Medtronic MiniMed Insulin Pumps.

“Medtronic is recalling the specified insulin pumps due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump’s reservoir compartment,” the MiniMed recall notice warned. “If the cartridge is not locked firmly into place, under or over delivery of insulin may occur, which could result in hypoglycemia or hyperglycemia. Severe hyperglycemia can result in a loss of consciousness, seizure, and death.”

At least one patient has died because of this problem, while more than 2,100 were injured. Medtronic has also received over 26,400 complaints of MiniMed pump malfunctions related to this issue.

In February 2020, the FDA declared the Medtronic MiniMed insulin pump recall a Class 1 recall, indicating use of the device may lead to serious injury or death.