BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1062354 · Received June 18, 2008

    Report

    Report Number
    1823260-2008-04798
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE NEEDLE FROM HE SOFTCLIX PLUS LANCET DEVICE PROTRUDES OUTSIDE THE END OF THE CAP AFTER IT WAS 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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR NOVOLIN: 70/30 80 UNITS DAILY - 5 YEARS| AVANDIA: 4MG TAB DAILY - 5 YEARS