BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 976821 · Received January 8, 2008

    Report

    Report Number
    1823260-2008-00311
    Event Type
    Malfunction
    Date Received
    January 8, 2008
    Date of Event
    October 17, 2007
    Report Date
    January 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE LANCET WOULD NOT RETRACT INTO THE ACCU-CHEK SOFTCLIX LANCET DEVICE AFTER FIRING. THE REPORTER WAS ACCIDENTALLY STUCK. NO MEDICAL INTERVENTION REQUIRED. NO ADVERSE EVENT REPORTED. THE ACCU-CHEK CUSTOMER CARE SERVICE CENTER SENT NEW DEVICE AND REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR