BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK SYSTEM

    MDR report key: 1780172 · Received September 21, 2007

    Report

    Report Number
    1823260-2007-08311
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    September 14, 2007
    Report Date
    September 21, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K962571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES, THE PATIENT TESTED 2.0 INR ON THE COAGUCHEK PST SYSTEM AND 5.2 INR ON A COMPARISON LAB. COUMADIN HELD FOR TWO DAYS DUE TO DEVICE RESULT, HOWEVER, NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK SYSTEM PROTHROMBIN TIME TEST STRIPS - GJS GJS ROCHE DIAGNOSTICS 567A-H10

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR WARAFIN - 4 MG/3DAYS, 3MG 3DAYS