Safety of Insulin Pumps Reviewed
Members of the FDA's General Hospital and Personal Use Devices Panel agreed that although there are technological issues with insulin infusion pumps, these are outweighed by user-related issues.
During 2006–2009, the FDA received 16,849 reports of adverse events (including 310 deaths) associated with insulin pumps; most were reported by the manufacturers. The reports were far from complete: In most cases the problem with the pump was not described, and the cause of death had not been thoroughly evaluated, according to the FDA. The most common device problems were listed as unknown (20%), replace (9%), display of an error message (almost 5%), failure to deliver (3%), and repair (3%).
Of the 310 deaths, the most commonly listed causes were diabetic coma, hyperglycemia, hypoglycemia, diabetic ketoacidosis, and unresponsiveness. There were 29 deaths associated with a motor vehicle.