BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAG-SENSE PT/INR MONITORING METER

    MDR report key: 24058666 · Received January 13, 2026

    Report

    Report Number
    MW5182188
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    July 7, 2025
    Report Date
    January 6, 2026
    Manufacturer
    COAGUSENSE INC
    Product Code
    GJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    "PATIENT WITH MECHANICAL/PROSTHETIC AORTIC VALVE ON LONG-TERM WARFARIN RELIED ON MDINR HOME INR METER/APP FOR ROUTINE INR MONITORING AND DOSING GUIDANCE WORKFLOW. ON (B)(6) 2025, PATIENT SUFFERED ISCHEMIC EMBOLIC STROKE AND WAS HOSPITALIZED. REVIEW OF HOME INR READINGS AROUND THE EVENT SHOWED BORDERLINE/SUB-THERAPEUTIC VALUES RELATIVE TO TARGET RANGE FOR MECHANICAL VALVE; THE APP LABELING DID NOT CLEARLY WARN OF LOW/SUB-THERAPEUTIC INR RISK. AFTER THE STROKE, MDINR INITIATED TROUBLESHOOTING/VERIFICATION STEPS VIA MULTIPLE PHONE CALLS THROUGH INR CLINIC NURSE, PROVIDED CALIBRATED TEST STRIPS (SHIPMENT DATED (B)(6) 2025), AND LATER REPLACED THE INR METER (SHIPMENT DATED (B)(6) 2025). VENOUS LAB COMPARISON TESTING WAS DISCUSSED BUT COULD NOT BE PERFORMED AT THE INR CLINIC. CONCERN IS POTENTIAL DEVICE/APP FAILURE OR INADEQUATE WARNING/ESCALATION FOR LOW INR IN A HIGH-RISK MECHANICAL VALVE PATIENT, CONTRIBUTING TO ANTICOAGULATION FAILURE AND EMBOLIC STROKE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125654 COAG-SENSE PT/INR MONITORING METER TEST, TIME, PROTHROMBIN GJS COAGUSENSE INC 200107

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other| H| S| L 2X MEDICATION NAME: MOUNJARO (TIRZEPATIDE).| CALCIUM.| METOPROLOL 100MG.| VITAMIN D.| WARFARIN 37MG.