Diabetes technology

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors

J Diabetes Sci TechnolPublished Descriptive analysis of Food and Drug Administration (FDA) adverse event database

Authors' conclusion

Creating tables based on manufacturer problem codes for their CGMs, followed by analysis of the adverse event text, facilitates the analysis of event causes. Analyzing adverse event data is the first step in trying to reduce the number of adverse events.

Study context

Population
Malfunction or injury adverse events for four CGM products in the US FDA database, 2022
Exposure
Dexcom G6 vs Abbott Libre vs Medtronic Guardian 3 vs Senseonics Eversense
Outcome
Causes of CGM adverse events
Methodological detailsCauses determined from adverse event text descriptions, as manufacturer product codes not always clear
  • Causes determined from adverse event text descriptions, as manufacturer product codes not always clear

Main finding

As reported in the abstract

  • A common effect of several event causes prevented the user from obtaining a result
  • Inaccuracy was also a frequent complaint
  • Other causes were specific to that device

Observational data: associations, not effects.

Original publication

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. J Diabetes Sci Technol. Published 1 June 2023. doi:10.1177/19322968231178525

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