BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS

    MDR report key: 1901793 · Received November 17, 2010

    Report

    Report Number
    2050012-2010-01293
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 9, 2010
    Report Date
    October 9, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO THE EVENT, ISE QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. ON (B)(6) 2010, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE CHLORIDE ELECTRODE, REBUILT THE RATIO PUMP, AND FLUSHED THE FLOW CELL. NO FURTHER CALLS WERE MADE TO THE BCI HOTLINE FOR ISE PROBLEMS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY HIGH SODIUM (NA) RESULTS FOR SIX PATIENT SAMPLES THAT WERE GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. SUBSEQUENT TESTING ON AN ALTERNATE INSTRUMENT PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY, BUT REPORTS WERE AMENDED BY THE SUBSEQUENT RESULTS. THE RESULTS FOR PATIENT #1 ARE PROVIDED. UNKNOWN IF TREATMENT WAS ADMINISTERED OR WITHHELD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1