BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1943349 · Received January 1, 2011

    Report

    Report Number
    2050012-2010-01770
    Event Type
    Malfunction
    Date Received
    January 1, 2011
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC SHOWED HIGH FLIERS. ON (B)(4) 2010, A BCI FIELD SERVICE ENGINEER (FSE) REPLACED SODIUM (NA) ELECTRODES, SAMPLES PROBE, WASH COLLAR, AND CARBON BRIDGE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED SODIUM (NA) RESULTS INTERMITTENTLY GENERATED BY UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. WHEN DELTA CHECK FAILED, THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT. REPEAT TESTING PRODUCED LOWER RESULTS WHICH WERE REPORTED. THERE WAS NO EFFECT TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1