BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1040977 · Received May 8, 2008

    Report

    Report Number
    1823260-2008-03850
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    May 3, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET STICKS OUT AFTER BEING FIRED WHILE USING THE MULTICLIX PLUS LANCET DEVICE. NO ACCIDENTAL STICK REPORTED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PROD 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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR NITROFURANTOIN 100 MG/DAY| PROMETHAZINE 25 MG AS NEEDED