Analysis of Adverse Events in Medical Devices for Diabetes
Authors' conclusion
This paper highlights the need to encourage the practice of reporting to generate evidence and to present strategies to mitigate adverse events, such as developing user-centered technologies inserted in an interdisciplinary ecosystem in the form of a living laboratory; considering accessibility aspects in development and incorporation; developing guidance resources for users; considering metrological aspects to ensure technological reliability; and including sustainability, security, and data privacy actions. Interconnectivity opens up opportunities for the ubiquitous management of technological processes throughout the life cycle.
Study context
- Population
- Adverse event notifications for home-use diabetes devices (blood glucose monitor (BGM), CGM, insulin pump)
- Comparison
- BGM vs CGM vs Insulin Pump
- Outcome
- Notifications on MAUDE-FDA
- Follow-up
- January 2019–December 2024
Methodological detailsANVISA Technovigilance Analytical Portal (Brazil) and MAUDE-FDA (USA), January 2019–December 2024
- ANVISA Technovigilance Analytical Portal (Brazil) and MAUDE-FDA (USA)
- January 2019–December 2024
Main finding
As reported in the abstract
BGM
52,601
events
CGM
1,624,664
events
Insulin Pump
1,339,652
events
Further findings
Mitigation strategies
- Strategies to mitigate adverse events presented, related to human, technological and environmental factors
Safety
- Main problems reported with the patient were hypoglycemia and hyperglycemia
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →