BLOOD GLUCOSE MONITOR ADVERSE INCIDENT REPORTS NEED COMPREHENSIVE ANALYSIS TO DETERMINE IF PUBLIC HEALTH PROBLEM EXISTS, ADVISORY COMMITTEE MEMBERS SAY
This article was originally published in The Gray Sheet
Executive Summary
Self-monitoring blood glucose system manufacturers and FDA need to do additional evaluation of adverse event reports on SMBG systems to get a better sense of the actual level of malfunction, misuse and risk associated with the devices, members of the Clinical Chemistry and Clinical Toxicology Devices Panel recommended at a March 20-21 meeting in Gaithersburg, Maryland.