BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1063747 · Received June 19, 2008

    Report

    Report Number
    1823260-2008-04841
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED A RESULT OF 4.4 INR ON THE COAGUCHEK XS SYSTEM AND 3.3 INR ON A COMPARISON LAB. NO ACTION TAKEN ON DEVICE RESULTS, HOWEVER, COUMADIN WAS CHANGED BASED ON LAB 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 20152223

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR LANOXICAPS - 2MG/DAY| THYROXINE - 1MG/DAY| CLONAZEPAM - 1MG/DAY