Continuous Glucose Monitor Retrospective Data Analysis Software
FDA adverse event reports and recall history for continuous glucose monitor retrospective data analysis software (product code PHV), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,045
- Deaths
- 0
- Injuries
- 8
- Malfunctions
- 2,037
Reports per year
Source: FDA adverse event reports by year received, 2017–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-11-25Open, ClassifiedSoftware change control
CareLink Clinic, REF: MMT-7350
Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.
- TerminatedSoftware design
CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.
Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.
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