Insulin Pump-Associated Adverse Events: A Qualitative Descriptive Study of Clinical Consequences and Potential Root...

Objective: To explore the clinical consequences and potential root causes of insulin pump-associated adverse events (AEs) reported in the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. Research Design and Methods: Qualitative template analysis of narrative data in a 20% stratified random sample (n = 2429) of reported AEs that occurred during the first 6 months of 2020 involving five insulin pump models marketed at that time: (1) MiniMed™ 670G, (2) MiniMed™ 630G, (3) Omnipod^®, (4) Omnipod DASH^®, and (5) t:slim X2™. Results: Of the 2429 AEs, 92% included a clinical consequence in the narrative description, with critical hyperglycemia (i.e., blood glucose [BG] >400 mg/dL; 47%) and critical hypoglycemia (i.e., BG <54 mg/dL; 24%) being the most common consequence cited. Only 50% of the AE narratives included information to support the identification of a root cause. The most cited root cause informing remarks were issues with the pump or pod reservoir/cartridge (9%), the occurrence of an obstruction of flow alarm (8%), and problems with the infusion set or site (8%). Some clinical consequences and root cause informing remarks were cited more frequently in AE narratives involving specific insulin pump models, but manufacturer variability in the amount and type of information reported may have affected these findings. Conclusions: Our findings show general themes found in insulin pump-associated AE that providers can use to raise patient awareness of potential risks associated with insulin pump use and develop strategies to prevent future AEs. Improvements in AE investigation and reporting processes are still necessary.