An Analysis of 2019 FDA Adverse Events for Two Insulin Pumps and Two Continuous Glucose Monitors

Abstract

US Food and Drug Administration adverse event data for 2019 were analyzed for two insulin pumps and two continuous glucose monitors (CGMs). The analyses were selective—they were guided by the text described in the adverse events. They included (1) percent using auto mode for the Medtronic 670G pump, (2) distributions of hyper and hypo glucose values for Medtronic and Tandem pumps, (3) a Parkes error grid for Dexcom CGM vs glucose meter when the complaint was inaccuracy, and (4) the most frequent events for Abbott Freestyle. We found that for the 670G pump, there were more hypo events when auto mode was on than when auto mode was off. With Dexcom CGMs, users complained about inaccurate result when most results were in the B zone. With the Abbott Freestyle, the most frequent adverse event was an allergic skin reaction.