BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1070172 · Received July 3, 2008

    Report

    Report Number
    1823260-2008-05177
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 24, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED 4.2 INR, 2.8 INR, AND 3.0 INR ON THE COAGUCHEK XS PLUS SYSTEM DURING DUPLICATE TESTING. PATIENT WAS TREATED ON 3.0 INR RESULT. 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 XS SYSTEM PROTHROMBIN TIME TEST STRIPS - GJS GJS ROCHE DIAGNOSTICS 20162831

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR COUMADIN