Dr. Gary Goldstein, a Florida internist, knew something was wrong with a blood-testing device in his office when, all of a sudden, it began giving out odd results.
The device, an INRatio monitor by Alere, is crucial to helping doctors manage patients on warfarin, a blood-thinning drug. When he checked the INRatio’s results against those from an outside laboratory and found they did not match, he got worried and called Alere. Then, he said, after sensing a lack of interest from the company, he filed a report about the event with the Food and Drug Administration.
