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More Info Needed on Problems With Insulin Pumps
Date:3/5/2010

s, and 4,294 malfunctions of pumps. The problems have been spread across various manufacturers and include both hardware and software issues.

While the reason for most of the deaths is unknown, a number were due to diabetic coma; blood sugar that was too low; blood sugar that was too high; diabetic ketoacidosis, a complication of diabetes; and unresponsiveness, according to the agency.

Since 2004, there have been 18 recalls of pumps. In many cases, the pump makers failed to identify and report the specific difficulties with the devices, according to the FDA. The agency has said that in most cases the manufacturers' response to the problems had been incomplete, including incomplete details about deaths related to the pumps.

Insulin pumps are small self-contained devices that supply measured doses of the hormone insulin to diabetics. The pumps are primarily used by people with type 1 diabetes, a disease in which the pancreas does not produce insulin, which is essential for controlling the body's blood sugar levels. In 2007, some 375,000 type 1 diabetics were using these pumps, according to the FDA.

The FDA asked the panel to consider several questions, including: What should be taken into account in looking at the risk of pump failure? Are there risks in patients changing from an insulin pump to another method of delivering insulin? What are the risks of using a defective pump? And what can be done to get manufacturers to do a better job of reporting and diagnosing pump problems.

The FDA isn't obligated to follow the recommendations of its advisory panels, but it typically does so.

More information

For more on the pumps and other alternate sources of insulin, visit the U.S. National Library of Medicine.



SOURCE: U.S. Food and Drug Administration; Dow Jones


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