BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1060114 · Received June 10, 2008

    Report

    Report Number
    1823260-2008-04608
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    June 7, 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
    NC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET PROTRUDES FROM THE END CAP OF THE SOFTCLIX PLUS 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 SOFTCLIX PLUS LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS BAT037

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR LEVEMIR, 20UNITS AM - 1 YEAR| NOVOLOG, SLIDING SCALE - 1 YEAR| LEVEMIR, 24UNITS PM - 1 YEAR