Device name: Insulin Pump
Approved uses: Designed to pump insulin into the blood stream in Type I or occasionally Type II diabetes patients.
• Software Failure
• Design Malfunctions
• Can cause incorrect insulin to be administered, which could lead to a diabetic coma or death.
Related topics: Diabetes, Insulin pump, Blood Sugar, Glucose, Type I, Type II
Diabetic Insulin Pump Information
A diabetic insulin pump is a device that delivers insulin to patients with Type I diabetes, a medical condition where the pancreas produces little or no insulin, a vital hormone responsible for breaking down sugars from food. Occasionally patients with Type II diabetes require a diabetes pump, although Type II is characterized by obesity and generally develops later in life.
After 18 insulin pump recalls in less than 5 years, the Food and Drug Administration is investigating the safety of the devices. A malfunctioning device can impact how much insulin is delivered to the patient, which could result in serious medical complications, including comas and death.
The number of people requiring insulin pumps has jumped by more than 185 percent since 2002. The FDA is currently reviewing safety features after a report indicated 17,000 problems were reported to the FDA. Although many of these problems could be attributed to misuse of the insulin pump, at least 310 deaths were reported. The cause of death has been listed as “unknown” for many of these patients, although enough evidence suggests that diabetic coma and other blood-sugar related problems may have been result of a malfunctioning insulin pump.
More than 375,000 patients in the U.S. rely on an insulin pump.
Insulin Pump Recalls Prompt Investigation
For many patients with Type I diabetes, an insulin pump makes it easy to receive the correct amount of insulin when needed.
However, the U.S. Food and Drug Administration is now reviewing the safety of the devices worn by close to 375,000 Americans after 18 insulin pump recalls have been announced in the last 5 years.
Many devices have reported problems in hardware or software which may cause the device to fail, or deliver the incorrect amount of insulin to a patient, which can result in a diabetic coma or even death.
In a report published by the FDA, nearly 17,000 adverse effects were reported by the manufacturers from Oct. 1, 2006 through Sept. 20, 2009. Of these, 12,000 patients reported patient injury, 310 of which resulted in death. Manufacturers are required to report potential problems, although these problems can be attributed to inadvertent misuse, however the FDA noted that the information provided regarding the deaths was “typically incomplete.”
Many deaths linked to diabetic comas or other glucose-related issues could be linked to a malfunctioning device. Insulin pumps are common amount patients with Type I diabetes, a condition where the pancreas does not produce enough insulin if at all. Insulin is an important hormone that regulates how the body processes sugars from food. Patients with Type II diabetes, which is characterized by obesity and usually develops later in life, can also use an insulin pump, although the need is not as substantial as a patient with Type I diabetes.
Problems with the device has prompted the FDA to review whether additional clinical trials will be necessary. The stricter regulation comes at a time when Type I diabetes rates has skyrocketed in the last 10 years – an increase of close to 188 percent since 2002.
Failures of the device pose a significant implication to a patient reliant on insulin. Although many of the recalls have been voluntary, many of the manufacturers have been named in lawsuits for device failure and other complications.
Patients and their families have sought compensation for costly medical treatments, especially for those who have experienced a coma or other serious effects of a failed insulin pump. Because many of these patients are unable to control diabetes without the help of an insulin pump, the safety of these devices is crucial.