BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    COAG-SENSE PT/INR MONITORING METER

    MDR report key: 24635061 · Received March 18, 2026

    Report

    Report Number
    3007507465-2026-00002
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    July 7, 2025
    Report Date
    January 26, 2026
    Manufacturer
    COAGUSENSE, INC.
    Product Code
    GJS
    PMA / PMN Number
    K212779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO FDA MDR REPORT # MW5183057, RECEIVED ON FEBRUARY 26, 2026, IT WAS DETERMINED THAT THIS REPORT WAS SUBMITTED BY THE SAME INDIVIDUAL AND CONTAINS INFORMATION DESCRIBING THE SAME EVENT THAT WAS REPORTED IN MDR REPORT # MW5182188. THE INITIAL MDR (# MW5182188) WAS RECEIVED ON FEBRUARY 10, 2026, AND A RESPONSE WAS SUBMITTED BY COAGUSENSE TO THE FDA ON MARCH 9, 2026 (MFR REPORT # 3007507465-2026-001). AS BOTH REPORTS PERTAIN TO THE SAME PATIENT AND EVENT, ALL SUBSEQUENT INVESTIGATION UPDATES WILL BE DOCUMENTED UNDER THE ORIGINAL MDR (# MW5182188).

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695327 COAG-SENSE PT/INR MONITORING METER TEST, TIME, PROTHROMBIN GJS COAGUSENSE, INC. 200107

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention| L| O CALCIUM.| METAPROLOL.| PROZAC| VITAMIN D.| WARFARIN.