BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1123946 · Received August 15, 2008

    Report

    Report Number
    1823260-2008-06270
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 11, 2008
    Report Date
    August 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER 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 BAS182

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR METOPROLOL - 2 YEARS| LISINOPRIL - 10 YEARS| NOVOLIN - OVER 1 YEAR| PLAVIX - 3 YEARS| HYDROCHLOROTHIAZIDE - 10 YEARS| LOVASTATIN - 3 YEARS