BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU400 CHEMISTRY SYSTEM

    MDR report key: 1786685 · Received August 5, 2010

    Report

    Report Number
    2050012-2010-00551
    Event Type
    Malfunction
    Date Received
    August 5, 2010
    Date of Event
    June 22, 2010
    Report Date
    August 4, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K981473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS AND COLLECTED IN SERUM SEPARATION TUBES (SST). THE CUSTOMER CLEANED AND INSPECTED THE MIX BARS. A BCI FIELD SERVICE ENGINEER (FSE) INSPECTED THE UNIT AND FOUND DETERGENT TANK ASPIRATION TUBE MISSING. DELIVERY OF CLEANING SOLUTION TO CUVETS AND MIX BAR WASH STATIONS WAS COMPROMISED. FSE REPLACED THE MISSING PART AND NO ADDITIONAL PROBLEMS WERE NOTED. NO TREATMENT WAS AFFECTED IN THIS CASE. OTHER CHEMISTRIES COULD BE IMPACTED UPON RECUR AND TREATMENT MAY BE IMPACTED. ROOT CAUSE FOR THIS EVENT IS USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS ELEVATED MAGNESIUM (MG) RESULT GENERATED BY UNICEL DXC AU400 CLINICAL CHEMISTRY SYSTEM. THE SAMPLE WAS REPEATED AND LOWER RESULT WAS OBTAINED. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. AMENDED REPORT WAS INITIATED. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU400 CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1