BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1011808 · Received March 11, 2008

    Report

    Report Number
    1823260-2008-02300
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE LANCET NEEDLE THAT IS PART OF THE SOFTCLIX PLUS DEVICE USED IN FINGER-STICK BLOOD GLUCOSE TESTING WOULD NOT RETRACT AFTER IT WAS USED AND PROTRUDED BEYOND THE END CAP. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT WAS RECEIVED. 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 BAT050

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INSULIN