An increasing number of hardware and software problems with insulin pumps, tiny devices worn by thousands of diabetics to deliver insulin, are being observed according to the US Food and Drug Administration (FDA).
Over a five-year period, there have been 18 recalls of devices, including recalls by a Roche Holding unit and Medtronic, the agency said.
The number of Type 1 diabetics using insulin pumps has increased, with about 375,000 US users in 2007, up from about 130,000 in 2002, the FDA said.
To minimise risks associated with the devices in these recall situations, the FDA is setting up an advisory panel of outside medical experts to discuss what actions might be taken, according to The Wall Street Journal.
A review of insulin pump-related adverse events conducted by the FDA found nearly 17,000 reports between 2006 and 2009, of which about 12,000 reported problems with blood glucose levels and 310 deaths.
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, the agency said.