BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1915991 · Received December 6, 2010

    Report

    Report Number
    2050012-2010-01537
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 7, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE CUVETTE WASH STATION PROBE WAS NOT ASPIRATING SO THE FSE REPLACED THE PROBE AND VACUUM VALVE. THE SAMPLE MIXER FLAGGED MOTION ERRORS DUE TO SAMPLE BEARING WAS NOT MOVING. THE FSE REPLACED THE PADDLE AND THE BEARING. ISE DAC (DATA ACQUISITION) ERROR ON CO2 (CARBON DIOXIDE) DUE TO THE GROUND WIRE WAS NOT COMPLETELY PLUGGED IN. THE FSE PERFORMED CALIBRATION AND QC. THE SYSTEM WAS RESUMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A SYSTEM FLAGGED ERROR MESSAGE WITH CUVETTES FAILED WATER BLANKS AND REACTION WHEEL TEMPERATURE ERRORS DUE TO AN OVERFLOW IN THE CUVETTES, LOCATED IN THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. NO INJURY WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1