BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2022875 · Received March 17, 2011

    Report

    Report Number
    2050012-2011-00694
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. QC WAS NOT RUN AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) BLEACHED AND CLEANED THE FLOW CELL. THE FSE REPLACED THE CARBON BRIDGE AND VERIFIED THE INSTRUMENT'S PERFORMANCE. A CLEAR ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSE SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS FOR TWO PATIENT SAMPLES. THE RESULTS WERE NOT REPORTED OUT OF THE LAB. WHEN THE RESULTS FAILED DELTA CHECK, THE SAMPLES WERE REPEATED AND THOSE RESULTS WERE REPORTED OUT OF THE LAB. PATIENT TREATMENT WAS NOT AFFECTED IN CONNECTION WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1