BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1962188 · Received January 17, 2011

    Report

    Report Number
    2050012-2011-00174
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE ISSUE USUALLY OCCURS ON THE DAY THAT ISE MAINTENANCE IS PERFORMED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT AND REPLACED THE ISE WASH COLLAR AND THE CALIBRATOR TIP. THE FSE ALSO CLEANED THE FLOWCELL, THE ELECTROLYTE INJECTION CUP (EIC) ASSEMBLY, AND CHANGED THE COLLAR WASH. THE FSE THEN FLUSHED THE MODULAR CHEMISTRY (MC) SAMPLE PROBE AND REPLACED THE CALCIUM TIP.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO RECOVERING LOW SODIUM (NA) PATIENT RESULTS AS WELL AS LOW NA QC RESULTS THAT WERE GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT IMPACTED IN THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1