BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1082574 · Received July 23, 2008

    Report

    Report Number
    1823260-2008-05698
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET STICKS OUT AFTER BEING FIRED WHILE USING THE SOFTCLIX PLUS LANCET DEVICE. CUSTOMER REPORTED HE ACCIDENTALLY STUCK HIMSELF; NO TREATMENT WAS RECEIVED. 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 BAU009

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR METFORMIN - 4 MONTHS| ASPIRIN - 3 YEARS| PRISOLEC - 4 YEARS| EFFEXOR - 1 YEAR AND HALF