Archive for the 'Glucose Meters' Category

Saturday, August 20th, 2005

A Brief History of Self-Monitoring of Blood Glucose with Glucose Meters

Anton Hubert Clemens received the first patent for a blood glucose meter called the Ames Reflectance Meter on September 14, 1971. Richard K. Bernstein, an insulin dependent physician with diabetes, was one of the first patients to monitor his blood glucose at home using a glucose meter. He published a report on his experiences in […]

Friday, August 19th, 2005

Diabetes Testing - Reporting Problems with Glucose Meters to FDA

FDA learns about problems with medical products through the MedWatch program. Consumers can report problems with medical devices, including glucose meters, through MedWatch.
For general information about the MedWatch program and instructions for reporting problems with medical devices, use the following link:
MedWatch: The FDA Safety Information and Adverse Event Reporting Program
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Thursday, August 18th, 2005

Diabetes Testing - How FDA Regulates Glucose Meters

FDA reviews all glucose meters and test strips before they can be marketed to the public. This FDA “premarket” review process requires the manufacturer of the meter to show that the meter system provides acceptable accuracy and consistency of glucose measurement at high, medium and low levels of glucose as compared to glucose meters already […]