BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1585196 · Received January 25, 2010

    Report

    Report Number
    2050012-2010-00016
    Event Type
    Malfunction
    Date Received
    January 25, 2010
    Date of Event
    January 5, 2010
    Report Date
    January 25, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE COLLECTED IN PLASTIC SST'S AND PST'S TUBES. ON (B)(4) 2010, THE ION SELECTIVE ELECTRODE (ISE) SYSTEM WAS CALIBRATED AND ALL QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. THE CUSTOMER WAS PROVIDED WITH THE TWICE-WEEKLY FLOW CELL MAINTENANCE PROCEDURE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE PERFORMED A PREVENTIVE MAINTENANCE (PM) AND REPLACED SEVERAL HARDWARE COMPONENTS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING LOW SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS. THE INITIAL RESULTS IN THE RANGE OF 130-139 MMOL/L WERE REPORTED OUT OF THE LAB THE SPECIMENS WERE RE-TESTED AND AMENDED REPORTS WERE ISSUED. THE ER PHYSICIAN STATED NO PATIENTS WERE TREATED BASED ON THE LOW NA RESULTS. ALL OF THE RESULTS WERE REVIEWED BY THE LAB'S MEDICAL DIRECTOR WHO STATED IT IS NOT LIKELY THAT PATIENT TREATMENT WOULD BE AFFECTED BY THE LOW NA RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1