Medical Device Manufacturers Often Fail To Submit Timely Adverse Event Reports to FDA: Study

Study found that nearly 10% of all medical device-related adverse events were reported 180 days or more after manufacturers became aware of them.

Amid a surge in medical device recalls in recent years, a new study reveals that manufacturers failed to submit more than 600,000 adverse event reports on time over a three-year period.

The study, which was published in the journal The BMJ on March 12, indicates some medical device manufacturers wait more than a month to file about a third of all incidents involving patients with the U.S. Food and Drug Administration (FDA), despite federal regulations requiring they report these incidents to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database within 30 days.

Timely reporting of adverse events is essential for the FDA to identify safety risks quickly, enabling faster warnings and recalls that help prevent injuries and save lives. Failing to abide by these guidelines can allow dangerous defects to go undetected, delaying critical actions that could protect patients from serious harm.

For this study, researchers from Washington University School of Medicine in St. Louis examined if device manufacturers reported side effects within the 30-day time frame, analyzing data from the MAUDE database from September 2019 through December 2022.

The researchers reviewed data for more than 4.4 million reports, including 1.5 million injuries, 1.5 million malfunctions and more than 13,000 deaths.

According to the findings, only 70% of adverse events were reported within the 30-day regulatory requirement. Of the remaining third not filed with the FDA in a timely manner, most were submitted more than six months after the deadline.

The data showed 4% of the reports were received between 31 and 180 days, but 9% were received later than 180 days. In addition, 16% of the reports submitted were missing information or had invalid data provided by the manufacturer. Researchers noted that three manufacturers and 15 medical devices accounted for more than half of the late reports.

Most Late Reports Linked to a Few Manufacturers

The top 10 manufacturers with the highest number of late reports were Becton Dickinson, Medtronic, Dentsply, Abbott, Boston Scientific, Nobel Biocare, Dexcom, Altatec, Biohorizons Implant Systems and Institut Straumann. They did not specify the top three.

The devices with the greatest number of late reports included Becton Dickinson’s infusion pumps, Abbott’s glucose monitors, Medtronic’s insulin pumps, Biohorizons Implant Systems’ dental implants and Dexcom’s glucose monitors.

Both Abbott’s glucose monitors and Medtronic’s insulin pumps have been plagued by recalls in recent years. Medtronic insulin pumps have suffered battery failures and other problems that have led to a number of wrongful death lawsuits.

More than 4 million of Abbott’s Libre glucose monitors were recalled in 2023 due to extreme overheating and fires. Other Abbott glucose monitor recalls were issued due to faulty results that could lead to patient side effects, including death.

“This study found that during a recent three-and-a-half-year period, nearly a third of initial manufacturer reports of adverse events in the MAUDE database were not demonstrably reported on time, with over two thirds of late reports submitted more than six months after manufacturer notification of events,” the researchers concluded. “MAUDE is an incomplete data source for understanding medical device safety issues, due partly to the timeliness of its reports.”