Adverse incidents: in vitro diagnostic (IVD) blood glucose meters

The document outlines reporting guidelines for IVD blood glucose meters used in POCT or home use. Adverse incidents such as display issues, performance errors, and design/manufacturing flaws are reportable. Manufacturers must provide detailed information on each incident, including patient symptoms, meter readings, and manufacturer's actions. The final vigilance report should include a clinical assessment, manufacturer's final assessment, and corrective actions taken by the manufacturer to prevent future incidents.