BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT TOUCH II

    MDR report key: 1060110 · Received June 10, 2008

    Report

    Report Number
    1823260-2008-04604
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    May 20, 2008
    Report Date
    June 10, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET PROTRUDES FROM THE END CAP OF THE SOFT TOUCH DEVICE AFTER FIRING. NO ACCIDENTAL NEEDLE STICK OCCURRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT TOUCH II LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR METFORMIN - 3 MONTHS| NOVOLIN 70/30 - 9 MONTHS