BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1220073 · Received October 31, 2008

    Report

    Report Number
    1823260-2008-08082
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 BAT021

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR NOVOLOG SLIDING SCALE -3 YEARS| LANTUS 50 UNITS/DAILY -3 YEARS