BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1002663 · Received February 8, 2008

    Report

    Report Number
    1823260-2008-01382
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 23, 2008
    Report Date
    February 8, 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

    CUSTOMER REPORTS LANCET WILL NOT RETRACT BACK INTO THE SOFTCLIX PLUS DEVICE AFTER FIRING. ACCIDENTAL NEEDLE STICK OCCURRED; NO MEDICAL TREATMENT REQUIRED. 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 BAT047

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR LANTUS 10UNITS 1/DAY 2 WEEKS