BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1232792 · Received November 14, 2008

    Report

    Report Number
    1823260-2008-08436
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 14, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED IN A CONDITION THAT MADE ANALYSIS IMPOSSIBLE- DEVICE COULD NOT BE PRIMED DUE TO DEFECTIVE FIRING BUTTON.

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET STICKS OUT AFTER BEING FIRED WHILE USING THE SOFTCLIX PLUS LANCET DEVICES. 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 PLUS LANCET DEVICE LANCET DEVICE-FMK FMK ROCHE DIAGNOSTICS BAT050

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR