BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1181932 · Received September 22, 2008

    Report

    Report Number
    1823260-2008-07073
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE LANCET DOES NOT RETRACT BACK INTO THE CAP OF THE ACCU-CHEK MULTICLIX LANCET DEVICE AFTER FIRING. THE CUSTOMER WAS ACCIDENTALLY STUCK WITH THE PROTRUDING LANCET. NO MEDICAL TREATMENT REQUIRED. NO ACTION TAKEN OR TREATMENT GIVEN BASED ON THE LANCET DEVICE ISSUE. 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 79 YR NOVOLOG - 3-4 WEEKS| "EVEMERE" - 3-4 WEEKS