Insulin Pump-Associated Adverse Events in a Brazilian Reference Center for the Treatment of Diabetes Mellitus: Proposal for a Taxonomy of Device Failures in Adults, Adolescents, and Children
Authors' conclusion
The study describes in a taxonomic format the AEs directly associated with the use of modern CSIIs that may contribute with additional information to the Food and Drug Administration (FDA) Medical Device Report (MDR) adverse event codes. In addition to guiding educational actions in the treatment of DM and providing information for health professionals and medical device developers, prospective studies examining the frequency of such problems, including the potential psychosocial impact of this technologically advanced therapy, are needed.
Study context
- Population
- Patients using different continuous subcutaneous insulin infusion (CSII) devices at a reference diabetes mellitus (DM) center in Brazil (adults, adolescents and children)
- Participants
- 118 patients
- Outcome
- Taxonomy of prevalent CSII-associated adverse events
Methodological detailssingle-centre, online interview
- Single-centre
- Online interview
Main finding
As reported in the abstract
CSII-associated AEs by taxonomy category
- CSII User Interface
- n = 45
- CSII Alert System
- n = 13
- CSII Software and Connection
- n = 11
- CSII Durability
- n = 30
- Electrical and Mechanical System of CSII
- n = 60
- Total adverse events (AEs) identified (incl. conflicting alerts, error/warning notification failures, engine malfunctions, data loss, patient interface deficiencies, button problems, battery failure)
- 159
Observational data: associations, not effects.
Original publication
Insulin Pump-Associated Adverse Events in a Brazilian Reference Center for the Treatment of Diabetes Mellitus: Proposal for a Taxonomy of Device Failures in Adults, Adolescents, and Children. J Diabetes Sci Technol. Published 30 June 2022. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →