BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1181943 · Received September 22, 2008

    Report

    Report Number
    1823260-2008-07076
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    September 13, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S DAUGHTER REPORTS LANCET STICKS OUT AFTER BEING FIRED WHILE USING THE SOFTCLIX LANCET DEVICE. NO ACCIDENTAL STICK REPORTED. 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 SOFTCLIX LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR NOVOLIN 70/30 - 10 YRS