BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1780599 · Received September 27, 2007

    Report

    Report Number
    1823260-2007-08473
    Event Type
    Malfunction
    Date Received
    September 27, 2007
    Date of Event
    September 5, 2007
    Report Date
    September 27, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THE CUSTOMER'S LANCET NEEDLE THAT IS A PART OF THE SOFTCLIX PLUS LANCING SYSTEM USED IN FINGER-STICK BLOOD GLUCOSE TESTING WOULD NOT RETRACT AFTER IT WAS USED. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT 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 BAT033

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR NAME AND DOSAGE UNK