BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEST, TIME, PROTHROMBIN

    MDR report key: 9864932 · Received March 23, 2020

    Report

    Report Number
    9864932
    Event Type
    Malfunction
    Date Received
    March 23, 2020
    Date of Event
    December 10, 2019
    Report Date
    March 11, 2020
    Manufacturer
    COAGUSENSE, INC
    Product Code
    GJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD AN INTERNATIONAL NORMALIZED RATIO (INR) DONE IN THE OFFICE. HIS INR WAS 2.1. HIS COUMADIN IS MANAGED BY THE COUMADIN CLINIC AND WHEN HE REPORTED IT TO THEM, HE WAS TOLD THAT IT DID NOT SEEM RIGHT. SO, HE WAS TOLD TO GO TO A LAB TO HAVE IT REPEATED. HE WENT TO THE LAB AND HAD THE INR REPEATED AND IT WAS 3.2. CALL RECEIVED FROM COUMADIN CLINIC THE FOLLOWING DAY TO REPORT THE DISCREPANCY OF THE PATIENTS INR READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332487 TEST, TIME, PROTHROMBIN GJS COAGUSENSE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1