BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1051728 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04112
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    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

    CUSTOMER REPORTS LANCET DRUM KEPT FALLING OUT WHILE USING THE MULTICLIX LANCET DEVICE. CUSTOMER REPORTS HER SON RECEIVED AN ACCIDENTAL STICK; COULD NOT REMEMBER SEEING A NEEDLE PROTRUDING. NO INFO WAS PROVIDED ON WHETHER LANCET PROTRUDED BEFORE OR AFTER FIRING. NO TREATMENT WAS RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALLERGY SHOTS ONCE/WEEK