BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1082587 · Received July 23, 2008

    Report

    Report Number
    1823260-2008-05694
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 13, 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
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE NEEDLE FROM THE SOFTCLIX PLUS LANCET DEVICE PROTRUDES OUTSIDE THE END OF THE CAP AFTER IT HAS BEEN FIRED. NO ACTIONS OR TREATMENTS WERE REPORTED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 37 YR LEVEMIR - 2 YEARS 40 UNITS ONCE| NOVOLOG - 2 YEARS SLIDING SCALE| METFORMIN- 6 MONTHS 500MG TWICE