BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU400

    MDR report key: 488064 · Received October 3, 2003

    Report

    Report Number
    8010047-2003-10076
    Event Type
    Malfunction
    Date Received
    October 3, 2003
    Date of Event
    June 26, 2003
    Report Date
    October 3, 2003
    Manufacturer
    OLYMPUS OPTICAL CO. LTD
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER WAS USING INCORRECT SET POINTS FOR CALIBRATOR AND PARAMETERS ON THE AU400 BECAUSE THE ANALYZER WAS PROGRAMMED INCORRECTLY. IT WAS BECAUSE THE CUSTOMER HAD NOT RECEIVED INFO ANNOUNCING THE REFORMULATION OF AN EXISTING PRODUCT (FERRITIN). UPON RECEIPT OF THE USER UPDATE ANNOUNCING THE REFORMULATION OF THE REAGENT, THE CUSTOMER REALIZED THE ERROR. FALSELY ELEVATED RESULTS WERE DETERMINED NOT TO BE MEDICALLY SIGNIFICANT. NO REPORTS OF ANY SERIOUS INJURY. THE NEW CALIBRATION SET POINTS WERE PROVIDED IN THE REAGENT PACKAGING BUT NOT IN THE CALIBRATOR. REAGENT PACKAGING WAS LABELED TO INDICATE THE CHANGES. THE ASSOCIATED USER UPDATE NOTIFICATION WAS NOT DISTRIBUTED UNTIL AUGUST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU400 AUTOMATED CLINICAL CHEMISTRY ANALYZER JJE OLYMPUS OPTICAL CO. LTD AU400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other