Insulin pump-associated adverse events: a qualitative descriptive study of clinical consequences and potential root causes.
Insulin pump malfunctions are a known contributor to adverse events. This study used six months of adverse events reported to the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to identify root causes and consequences of errors associated with insulin pump malfunctions. Hyper- and hypoglycemia were the most common clinical consequences of the malfunction; only half of the reports identified a potential root cause.