BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1041189 · Received May 9, 2008

    Report

    Report Number
    1823260-2008-03877
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE LANCET "STUCK OUT" OF THE ACCU-CHEK MULTICLIX LANCET DEVICE. THE ACCU-CHEK CUSTOMER CARE SVC CENTER AGENT CALLED THE REPORTER THREE TIMES TO OBTAIN CLARIFICATION ON THE LANCET PROTRUDING PAST THE CAP OF THE LANCET DEVICE BEFORE/AFTER FIRING. THE REPORTER DID NOT RESPOND TO THE CALLS. NO REPORTED ACTIONS/TREATMENT. NO ADVERSE EVENT REPORTED. NEW LANCET DEVICE WITH LANCETS SENT AND RETURN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK