BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS

    MDR report key: 1760001 · Received July 16, 2010

    Report

    Report Number
    2050012-2010-00480
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    June 17, 2010
    Report Date
    July 16, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE SERUM OR PLASMA. QC DATA WAS WITHIN SPECIFICATION PRIOR TO THE EVENT. A BCI SERVICE REPLACED CARTRIDGE CHEMISTRY SAMPLE PROBE. FSE CALIBRATED THE UNIT AND VERIFIED SYSTEM PERFORMANCE. SINCE SERVICE VISIT THE UNIT HAS BEEN OPERATING APPROPRIATELY. A CLEAR ROOT CAUSE CANNOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO MULTIPLE ERRONEOUSLY CARTRIDGE AND MODULAR CHEMISTRY RESULTS GENERATED BY UNICEL DXC 800 PRO CLINICAL SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE RETESTED ON ANOTHER UNIT AND THE RESULTS WERE WITHIN THE ESTABLISHED RANGE. ONE PATIENT WAS ADMINISTERED MG AND THE MG RESULT WAS LOWER THAN EXPECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1