BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK MULTICLIX

    MDR report key: 1061690 · Received January 3, 2008

    Report

    Report Number
    1823260-2008-00076
    Event Type
    Malfunction
    Date Received
    January 3, 2008
    Date of Event
    December 10, 2007
    Report Date
    January 3, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE LANCET WILL NOT RETRACT INTO THE ACCU-CHEK MULTICLIX LANCET DEVICE AFTER FIRING. NO ACCIDENTAL STICK OR 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 ACCU-CHEK MULTICLIX LANCET DEVICE-FMK FMK ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR GLUCOPHAGE 500MG/DAY 7 YEARS| GLYBURIDE 5MG/DAY 7 YEARS