Severe Insulin Pump-Related Adverse Events: Potential Root Causes and Impact of the COVID-19 Pandemic.

Abstract

To explore insulin pump-associated severe adverse events (SAEs) involving intensive care unit (ICU) admissions and deaths and examine the impact of the COVID-19 pandemic on these SAEs. Qualitative template analysis of narrative data in reported insulin pump-associated SAEs occurring between May 1, 2019, and January 31, 2021, involving MiniMed 670G, MiniMed 630G, Omnipod, Omnipod DASH, and t:slim X2 insulin pumps. Over the 21-month measurement period, 460 SAEs involving an ICU admission and 288 SAEs involving a death were reported to the Food and Drug Administration. Problems with the pump or pod reservoir/cartridge were among the most frequently cited potential root causes in SAEs involving ICU admissions and deaths overall. However, problems with the infusion set or site and the pump battery or power emerged in the top three potential root causes of SAEs involving an ICU admission, whereas the patient sleeping at the time of the event and the tasks of changing the pod/infusion set, including reservoir/cartridge and programming the pump emerged in the top three for SAEs involving a death. The median monthly number of reported SAEs involving ICU admissions and deaths decreased during the pandemic, but their potential root causes were unchanged. Although insulin pumps are generally safe, SAEs related to their components and external factors can and do occur. By learning from the potential root causes of insulin pump-associated SAEs, providers and patients can implement corrective actions to prevent future events, thereby reducing harm.