Insulin Pump Alarms During Adverse Events: A Qualitative Descriptive Study

Abstract

OBJECTIVE: Explore alarm signals cited in insulin pump-associated adverse events (AEs), describe the clinical consequences and other root cause informing remarks that cooccurred with the alarm signals, and identify opportunities for improvements to patient education, instructional materials, and alarm systems to prevent future AEs. RESEARCH DESIGN AND METHODS: We explored the type, frequency, and associated clinical consequences of alarm signals cited in a pre-coded data set of 2294 insulin pump-associated AEs involving the MiniMed 670G, MiniMed 630G, and t:slim X2. We also explored the clinical consequences and other root cause informing remarks that cooccurred with the top 10 most frequently cited alarm signals. RESULTS: Overall, 403 AEs narratives cited at least one alarm signal. Of the 40 unique alarm signals cited, 42.5% were "alarms," 25.0% were "alerts," and 32.5% were not referenced in the instructional materials packaged with the corresponding pump. The top 10 most frequently cited alarm signals included two obstruction of flow alarms, which accounted for 49.9% of all AEs citing at least one alarm, and two unreferenced alarms. The most frequent cooccurring root cause informing remark varied across the top 10 alarm signals and revealed valuable insight into why these alarms may have occurred. CONCLUSIONS: Our findings demonstrate the value of analyzing alarm signals cited in insulin pump-associated AEs and reveal multiple opportunities for providers to educate patients on how to respond to alarm signals and manage their pumps to avoid AEs, and for insulin pump manufacturers to update instructional materials and improve alarm systems to support appropriate patient response.