BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1003462 · Received February 21, 2008

    Report

    Report Number
    1823260-2008-01759
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS THE PT TESTED 2.8 INR ON THE COAGUCHEK XS SYSTEM AND 1.1 INR ON A COMPARISON LAB. NO ACTIONS TAKEN ON DEVICE 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 20159631

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR PLAQUENIL - 200MG/DAY| COUMADIN - 12MG-10MG/ALTERNATING