Description of Event or Problem · 0
I WAS PRESCRIBED AND USED A COAG-SENSE HOME INR MONITORING SYSTEM TO MANAGE MY WARFARIN THERAPY. THE DEVICE WAS USED ACCORDING TO INSTRUCTIONS FOR HOME INR TESTING. OVER TIME, THE DEVICE PRODUCED INR READINGS THAT WERE INCONSISTENT WITH LABORATORY-CONFIRMED INR VALUES OBTAINED THROUGH VENOUS BLOOD DRAWS. THESE INACCURATE READINGS LED TO IMPROPER WARFARIN DOSING DECISIONS. THE HOME DEVICE READINGS SUGGESTED INR VALUES THAT WERE SIGNIFICANTLY DIFFERENT FROM LABORATORY RESULTS, CREATING A FALSE SENSE OF THERAPEUTIC CONTROL. AS A RESULT OF INACCURATE INR MONITORING, MY ANTICOAGULATION THERAPY WAS NOT PROPERLY MANAGED. I EXPERIENCED SERIOUS MEDICAL CONSEQUENCES CONSISTENT WITH UNDER- OR OVER-ANTICOAGULATION, INCLUDING NEUROLOGICAL INJURY AND STROKE-RELATED SYMPTOMS. THESE EVENTS REQUIRED MEDICAL EVALUATION AND ONGOING CARE. DUE TO LOSS OF CONFIDENCE IN THE ACCURACY OF THE COAG-SENSE DEVICE, I WAS FORCED TO DISCONTINUE ITS USE AND SWITCH TO ALTERNATIVE MONITORING METHODS. THE DEVICE FAILURE DIRECTLY IMPACTED MY MEDICAL TREATMENT, SAFETY, AND LONG-TERM HEALTH OUTCOMES. THE INACCURATE DEVICE READINGS WERE DISCOVERED AFTER COMPARISON WITH LABORATORY INR TESTING AND CLINICAL EVALUATION. THE HARM OCCURRED DURING NORMAL, INTENDED USE OF THE DEVICE.