Adverse Event Data for Years 2018 to 2020 for Diabetes Devices.

Unlike performance evaluations, which are often conducted under ideal conditions, adverse events occur during actual device use for people with diabetes. This report summarizes the number of adverse events for the years 2018 to 2020 for the 3 diabetes devices: blood glucose meters (BG), continuous glucose monitors (CGM), and insulin pumps. A text example of a CGM injury is provided. Possible reasons are suggested for trends. Whereas the rate per test result (events/usage) is exceedingly small, the rate per patient (events/people with diabetes that use insulin) is of concern. Hence, it is important to determine event causes and provide corrective actions. The first step is to put in place routine analysis of adverse event data for diabetes devices.