Insulin Pump Dangers
Insulin pump failures and defects are a serious and potentially deadly problem.The Food and Drug Administration announced last week that it has seen an increasing number of hardware and software problems with insulin pumps, tiny devices worn by thousands of diabetics to deliver insulin.
The FDA noted that critical insulin pump problems seem to exist across manufacturers. There have been 18 recalls of devices over a five-year period, including recalls by a Roche Holding AG unit and Medtronic.
The FDA is convening an advisory panel of outside medical experts to discuss what actions might be taken to minimize risks associated with the devices in these recall situations
Insulin pumps are primarily used by people with Type I diabetes, a condition in which the pancreas produces little or no insulin, a hormone needed to help the body properly use sugars from foods. People with Type 1 diabetes need to administer insulin daily whether through a pump or other methods like shots.
The more common form of diabetes, Type 2, which is often associated with obesity and typically develops later in life, is managed with oral medications designed to help the body properly use insulin, although some cases do require insulin.
The FDA said the number of Type I diabetics using insulin pumps has increased, with about 375,000 U.S. users in 2007, up from about 130,000 in 2002.
Manufacturers are required to report problems potentially associated with devices to the FDA. The FDA conducted a review of insulin pump-related adverse-event reports and found nearly 17,000 reports from Oct. 1, 2006, through Sept. 30, 2009. The reports don't necessarily mean a device caused a problem but serve as a signal for more investigation. Even if a device is functioning properly patients can inadvertently misuse the device. Of the reports, about 12,000 reported a patient injury (such as problems with blood glucose levels) and 310 deaths.
The agency said the information provided by manufacturers involving deaths "was typically incomplete." The agency said in 225 of the deaths reported the device problem was listed as "unknown," although in many cases the device was never returned to the manufacturer for additional follow-up.
However, in 41 death reports, a device problem wasn't identified but the circumstances involving the death involved diabetic coma and problems associated with blood-sugar levels being too high or too low, suggesting the device may not have been working properly.
