FDA Meeting Today to Review Mounting Problems with Insulin Pumps

A panel of outside advisers to the FDA are scheduled to meet today to review what steps the regulatory agency might take to reduce the risk of potentially serious problems for diabetics caused by insulin pumps. The FDA has noted a disturbing number of problems with insulin pumps, which are growing in popularity.

Insulin pumps are small medical devices worn by Type 1 diabetics that provide an alternative to daily injections of insulin by syringe or an insulin pen.

According to information released this week in advance of an advisory panel meeting in Gaithersburg, Md., the FDA indicates that it has received nearly 17,000 adverse event reports involving insulin pumps since October 2006, with 310 involving the death of the person using the device. In addition, there have been a number of insulin pump recalls in recent years among different manufacturers, with 18 recalls for insulin pump products issued between October 2004 and May 2009.

Last summer, a recall was issued for Medtronic Paradigm insulin pump Quick Sets was issued after the company determined that about 60,000 infusion sets used with the pumps were defective and could give too much insulin to users due to an air pressure problem. A number of Medtronic insulin pump lawsuits have been filed over diabetic-related injuries resulting from the defective infusion sets. The FDA issued a warning letter to the company over its manufacturing processes, noting that it had quality assurance problems and that the on-site medical professional hired to determine if there was a medical problem with the devices had only a high school diploma.

In an infusion set background report (pdf) issued to the FDA’s General Hospital and Personal Use Devices Panel, reviewers noted that the problem was not limited to Medtronic.

“Device problems critical to insulin pumps exist across manufacturers,” the report notes. Reviewers also said that the device manufacturers have failed to identify problems in the bulk of the adverse event reports they have received from insulin pump users, and in a large number of reports, it appears the manufacturers did not even try. Insulin pump manufacturers also have failed to investigate cause of deaths associated with their devices.

FDA reviewers found that the most common cause of death and injury from the use of either defective insulin pumps or from using them incorrectly was hypoglycemia; lower than normal blood glucose. However, the FDA also has identified a growing number of insulin pump-related automobile accidents.

Between 2006 and 2009, there were at least 29 adverse event reports of motor vehicle accidents associated with insulin pumps. In some cases, drivers wearing insulin pumps and suffering from low glucose levels lost consciousness or died while driving and crashed into other vehicles, drove off the road, into lakes, and even slammed into buildings at high speed.