BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1770861 · Received November 12, 2007

    Report

    Report Number
    1823260-2007-09846
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 25, 2007
    Report Date
    November 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET STICKS OUT AFTER BEING FIRED WHILE USING THE MULTICLIX LANCET DEVICE. 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 57 YR