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A U.S. Food and Drug Administration panel said insulin-pump manufacturers should try to provide more information to the agency when filing reports about potential pump problems.

Medical-device manufacturers are required to report when a device might have contributed to a death or serious injury of a patient or when a device malfunctions. The FDA said it has seen a sharp rise in the number of reports related to insulin pumps, some of which is related to increased use of the pager-sized devices in recent years. The pumps are designed to deliver insulin on a continuous basis through a catheter that is inserted into the body.

The panel of outside medical experts met Friday to discuss the increase in medical-device reports and whether anything could be done to minimize potential risks to patients.

But panel members said more information is needed in device adverse-event reports to help the FDA figure out if the device was the cause of a particular problem. They acknowledged that it is difficult to get background information from patients who might call to report a problem to a company or get the devices returned for evaluation.

"It could be a pump failure or it could be people failure," said Marc Rendell, a panel member and director of the Diabetes Center at Creighton University in Omaha, Neb., explaining that it can be difficult to train patients to properly use the devices. Several other doctors on the panel also said they find many pump problems are the result of patients not following instructions, such as changing some pump parts every three days or using the proper settings.

"Device problems critical to insulin pumps exist across manufacturers," the agency said in a document prepared for the meeting. The FDA said there have been 18 recalls of devices over a five-year period, including recalls by a Roche Holding AG (RHHBY, ROG.VX) unit and by Medtronic Inc. (MDT). Of the 18 recalls, however, only three were considered serious and potentially life-threatening. The agency said it has seen an increase in the number of hardware and software problems.

Other device manufacturers include Abbott Laboratories (ABT), Hospira Inc. (HSP) and a unit of Johnson & Johnson. (JNJ), according to the FDA.

Insulin pumps are used primarily 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 such as injections.

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 the use of insulin.

The FDA said the number of Type I diabetics using insulin pumps has increased, to about 375,000 U.S. users in 2007, from about 130,000 in 2002.

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 that, 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.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

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