Consumers report glucose meter problems to FDA.
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.


CONCLUSIONS
The FDA gains valuable insight from and encourages user reports.
Gutman
Steven I
SI
Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Rockville, Maryland 20850, USA.
Fuller
Janie G
JG
Hausman
Ethan D
ED
D015190:Blood Glucose Self-Monitoring / Q000592:standards*; D003256:Community Participation; D006801:Humans; D011785:Quality Assurance, Health Care; D014481:United States; D014486:United States Food and Drug Administration