Lately, the Food and Drug Administration has been receiving increased numbers of reports describing problems with insulin pumps, those small devices used by diabetics to deliver insulin without the need for injections.
The FDA noted that various hardware and software issues have resulted in 18 device recalls during the last 5 years.
“Device problems…exist across manufacturers,” the agency noted.
In response, FDA has convened an advisory panel to recommend actions to “minimize risks associated with the devices in these recall situations,” according to its Web site.
Insulin pumps are typically used by patients with Type I diabetes, in which the pancreas produces little or no insulin. Type 1 diabetics rely on exogenous insulin for survival.
According to the FDA, the number of people in the US who used insulin pumps increased from 130,000 in 2002 to 375,000 in 2007.
The FDA requires pump makers to report problems and potential problems associated with the devices. The agency received 17,000 such reports in the 3-year period ending September 30, 2009. Such reports don’t necessarily mean the pump caused a problem but usually merit further investigation. Patients can misuse a properly functioning pump, for example.
Roughly 12,000 reports to the FDA were associated with a patient injury (which typically involved gyrating blood glucose levels). Deaths occurred 310 times.
In these instances, the FDA said information provided by pump makers “was typically incomplete.” In 225 of these reports, the manufacturer listed the device problem as “unknown.” In many of these cases, the device wasn’t returned to the manufacturer for follow-up investigation.
In 41 reports involving a patient death, the circumstances included diabetic coma and other problems typically associated with severe abnormalities in blood-sugar levels, which suggests possible device malfunctioning.