Since 2008, insulin pumps and their components have been the subject of more malfunction, injury and death reports than any other medical device.
During that time, the Food and Drug Administration’s medical device database received a number of injury reports for these devices second only to reports involving metal hip replacements. Yet the problems with metal hip replacements have been widely reported. injuries from insulin pumps have received little press coverage, even though the devices are used by hundreds of thousands of people around the world, including children.
According to a recent report, user error is often blamed for problems with the pumps. After all, these are complex devices requiring special training to operate.
“There is a sharp learning curve,” says the medical director of the University of Florida’s Diabetes Institute. “You’ve got to understand the pump. You’ve got to understand how it works…. You’ve got to understand how to change it. You have to understand settings.”
The pumps help many people manage their diabetes. And, they may be safer than injections, which have been the traditional treatment.
Yet a joint investigation by the Associated Press and the International Consortium of Investigative Journalists found that, over the last 10 years, Medtronic insulin pumps and components have been subject to 20 recalls and approximately 100 lawsuits after alleged malfunctions.
A 2015 study discovered that roughly 40 percent of users experienced problems with their insulin pumps. A minority of those, especially children, needed hospital management. It also found that the failure rates of insulin pumps don’t seem to improve despite technological advances.
The AP notes that, when doctors or manufacturers file adverse event reports on medical devices, they are supposed to include a device problem code and an explanation of what went wrong. This is crucial if the FDA’s data is to be able to identify trends. Unfortunately, Medtronic included the device problem code on only 2 percent of the over 150,000 death and injury reports it has filed regarding insulin pumps since 2008. It marked “no conclusion can be drawn at this time” as the cause in over 80 percent of those reports.
The FDA notes there have been fewer insulin pump recalls over the past five years than in the previous five. However, the AP points out that one of the most serious recalls, which involved failure to deliver the correct insulin, occurred in 2013.
The potential harm from a faulty insulin pump can be serious, including coma and even death. People who suspect they have been harmed by a defective insulin pump or component should discuss their situation with an experienced personal injury attorney right away.