Insulin pumps have the most reported problems among all medical devices, a new report has shown.
Insulin pumps and their components have the most overall number of malfunctions, injury and death reports in the FDA’s database, according to an Associated Press analysis of reports. In terms of injuries, the pumps were second only to metal hip replacements, which have well-documented side effects. Insulin pumps, by contrast, have flown under the radar.
Experts and medical device companies blame user error for most of the reported problems and claim that insulin pumps help diabetics lead normal lives. The pumps, they say, are complex devices that require special training for patients.
Over the last ten years, insulin pumps and pump parts made by Medtronic Inc. were subject to 20 recalls and 100 lawsuits alleging pump defects.
Insulin pumps are compact computerized devices that are designed to mimic a person’s pancreas. They have two main components: the pump and the infusion set. Patients must maintain the device, monitor their diets and input information manually, including the rate of insulin delivery.
Companies have aggressively marketed the device to adults and children, but experts say the device may not be a good fit for everyone. They say potential users should be screened to ensure they’re suitable candidates.
The FDA’s database does not provide an explanation as to why the devices have created so many adverse events. Many of the reports from doctors, manufacturers and patients are missing critical information.
The FDA says the device makers should include a problem code when they file an adverse event report, but they are not required to if the information is unknown.
AP’s analysis of the FDA’s data found that Medtronic did not include problem codes in virtually any of its reports of deaths and injuries, which total more than 150,000.