Insulin Pump-Associated Adverse Events: A Qualitative Descriptive Study of Clinical Consequences and Potential Root Causes
Authors' conclusion
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.
Study context
- Population
- Insulin pump-associated adverse events (AEs) reported in the FDA MAUDE database, first 6 months of 2020, involving five pump models: MiniMed 670G, MiniMed 630G, Omnipod, Omnipod DASH, t:slim X2
- Participants
- 2,429 reported AEs
- Outcome
- Clinical consequences and root causes in AE narratives
Methodological detailsqualitative template analysis, 20% stratified random sample
- Qualitative template analysis
- 20% stratified random sample
Main finding
As reported in the abstract
- AEs including a clinical consequence in the narrative
- 92%
- Critical hyperglycemia (BG >400 mg/dL)
- 47%
- Critical hypoglycemia (BG <54 mg/dL)
- 24%
- AE narratives with information supporting root cause identification
- 50%
- Root cause remark: pump or pod reservoir/cartridge issues
- 9%
- Root cause remark: obstruction of flow alarm
- 8%
- Root cause remark: infusion set or site problems
- 8%
Original publication
Insulin Pump-Associated Adverse Events: A Qualitative Descriptive Study of Clinical Consequences and Potential Root Causes. Diabetes Technol Ther. Published 1 February 2023. doi:10.
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