BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1770970 · Received November 13, 2007

    Report

    Report Number
    1823260-2007-09877
    Event Type
    Malfunction
    Date Received
    November 13, 2007
    Date of Event
    November 5, 2007
    Report Date
    November 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER STATES, THE LANCET DOES NOT RETRACT INTO THE SOFTCLIX LANCET DEVICE. 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 LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS WIR037

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR BYETTA - <1 YEAR 20MG/DAY| GLYBURIDE - "YEARS" - 20MG/DAY| ACTOS - 15 MG/DAY