BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2230179 · Received September 1, 2011

    Report

    Report Number
    2050012-2011-04973
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    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 THE LABORATORY'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND REPLACED BOTH NA ELECTRODES, CL TIP, FLOWCELL CARBON BRIDGE, MODULAR CHEMISTRY (MC) SAMPLE PROBE AND ELECTROLYTE INJECTION CUP (EIC) SEALS. FSE ALSO CLEANED EIC PORTS AND RE-ALIGNED SAMPLE PROBE TO EIC AND VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER GENERATED FALSE HIGH SODIUM (NA) AND CHLORIDE (CL) RESULTS. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. WHEN THE ANION GAP FLAGGED A SAMPLE, IT WAS REPEATED ON A DIFFERENT INSTRUMENT IN THE LABORATORY AND THOSE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN. THERE WAS NO AFFECT TO PATIENT WITH REGARD TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1