BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK S SYSTEM

    MDR report key: 1122805 · Received August 14, 2008

    Report

    Report Number
    1823260-2008-06201
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 14, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JPA
    PMA / PMN Number
    K994349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE TROUBLESHOOTING WITH THE MFR, THE CUSTOMER REPORTED A MISSING ICON ON THE COAGUCHEK S METER DISPLAY. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK S SYSTEM PROTHROMBIN TIME MONITOR-JPA JPA ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK