BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1140528 · Received August 28, 2008

    Report

    Report Number
    1823260-2008-06508
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED A RESULT OF 4.6 INR ON THE COAGUCHEK XS AND 3.3 INR ON A COMPARISON LAB. NO TREATMENT INFO PROVIDED. 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 20163821

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR PROZAC| IRON| ZOCOR| WARFARIN| ZYRTEC| SIMVASTATIN| FLONASE| "ACYCLINOVIS"