BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1191523 · Received September 26, 2008

    Report

    Report Number
    1823260-2008-07186
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 14, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET STICKS OUT WHILE USING THE MULTICLIX LANCET DEVICE. NO INFO WAS PROVIDED ON WHETHER LANCET PROTRUDED BEFORE OR AFTER FIRING. NO ACCIDENTAL STICK REPORTED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE 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