BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1002125 · Received February 20, 2008

    Report

    Report Number
    1823260-2008-01716
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 PLUS LANCET DEVICE. NO ACCIDENTAL STICK REPORTED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PROD 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 BAT052

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HUMALOG 7 UNITS 3X/DAY| HUMULIN 16 UNITS 2X/DAY