BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 1980859 · Received February 7, 2011

    Report

    Report Number
    2050012-2011-00390
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    2050012-01/11/2010-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO AND AFTER THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. THE CUSTOMER CALIBRATES THE UNIT EVERY 24 HOURS AND RAN QC EVERY 4 HOURS. A BCI FIELD SERVICE ENGINEER (FSE) INSTALLED NEW ION-SELECTIVE ELECTRODE (ISE) RATION PUMP, DECONTAMINATED THE ISE AND REPLACED CARBON BRIDGE. FSE PERFORMED PMC AND MODIFICATION PER PCA REPORT NUMBER 2050012-01/11/2010-001C. FDA RECALL NUMBER Z-0863-2010.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO HIGH SODIUM (NA), POTASSIUM (K), CHLORIDE (CL), AND CARBON DIOXIDE (CO2) RESULTS ON ONE PATIENT GENERATED ON THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE NA RESULT WAS REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED ON THE SAME UNIT AND AN ALTERNATE UNIT AND LOWER ACCEPTABLE RESULTS WERE OBTAINED AND REPORTED. UNKNOWN IF TREATMENT WAS INITIATED OR WITHHELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER. CLINICAL CHEMISTRY ANALYZER, JGS BECKMAN COULTER INC. DXC600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR