BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1083762 · Received July 24, 2008

    Report

    Report Number
    1823260-2008-05749
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET STICKS OUT WHILE USING THE SOFTCLIX PLUS LANCET DEVICE. CUSTOMER DOES NOT KNOW IF NEEDLE WAS PROTRUDING BEFORE OR AFTER FIRING. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR HUMALOG 6-7 YEARS| HUMULIN NPH 6-7 YEARS