RESUMO
OBJECTIVE: Glucose meters have unquestionable clinical utility, particularly in management of diabetes mellitus. U.S. Food and Drug Administration (FDA) surveillance activities include monitoring adverse event reports from healthcare professionals, manufacturers, and lay users. METHODS: To gain insight into problems reported to FDA on glucose meters, we analyzed reports received over a 3-year period (2000-2002) from all sources (mandatory and voluntary) and focused on reports from users. RESULTS: The vast majority of in vitro diagnostic device (IVD) reports (84%, n = 18,959) were on glucose meters, with 333 glucose meter reports from users. Among the user reports, the most common problems were false high or low values and erratic values. Unique issues reported included purchase of incorrect glucose meter strips, calibration problems, and misunderstanding how FDA regulates glucose device performance. CONCLUSION: The FDA gains valuable insight from and encourages user reports.
