BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1070170 · Received July 3, 2008

    Report

    Report Number
    1823260-2008-05174
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    May 9, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS THAT DURING A CORRELATION STUDY, THE FOLLOWING COAGUCHEK XS/LABORATORY RESULTS WERE OBTAINED: 2.1 INR/1.68 INR. NO TREATMENT INFORMATION PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM; HOWEVER, CALLER NO LONGER HAS THE TEST STRIPS; 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 71 YR COUMADIN - BEGAN 2 MONTHS AGO