BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1780347 · Received September 12, 2007

    Report

    Report Number
    1823260-2007-07965
    Event Type
    Malfunction
    Date Received
    September 12, 2007
    Date of Event
    August 17, 2007
    Report Date
    September 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS THAT DURING A CORRELATION STUDY, THE FOLLOWING COAGUCHEK XS / LABORATORY RESULTS WERE OBTAINED: 2.5 INR / 1.9 INR. NO TREATMENT INFO PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT SENT.

    Description of Event or Problem · 2

    CALLER REPORTS THAT DURING A CORRELATION STUDY, THE FOLLOWING COAGUCHEK XS / LABORATORY RESULTS WERE OBTAINED: 3.1 INR / 2.3 INR. NO TREATMENT INFO PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK XS SYSTEM PROTHROMBIN TIME TEST STRIPS - GJS GJS ROCHE DIAGNOSTICS 20151133

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR COUMADIN - 2MG/DAY ON THURSDAYS| COUMADIN - 1MG/DAY SUN,M,W,F,SAT
    2 COUMADIN 5MG/DAY