BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1770693 · Received October 29, 2007

    Report

    Report Number
    1823260-2007-09420
    Event Type
    Malfunction
    Date Received
    October 29, 2007
    Date of Event
    October 9, 2007
    Report Date
    October 29, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE NEEDLE FROM THE MULTICLIX LANCET DEVICE PROTRUDES OUTSIDE THE END OF THE CAP AFTER IT HAS BEEN FIRED. NO ACTIONS OR TREATMENTS WERE REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK MULTICLIX LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 2 MONTHS AGO| AVANDAMET - 1000 MG TWICE DAILY, 2 YEARS UNTIL| LANTUS - 14 UNITS NIGHTLY, 1 YEAR