BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON CLINICAL SYSTEM

    MDR report key: 1961962 · Received January 15, 2011

    Report

    Report Number
    2050012-2011-00165
    Event Type
    Malfunction
    Date Received
    January 15, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC IS WITHIN THE ESTABLISHED RANGES. A BCI FIELD SERVICE ENGINEER (FSE) VISITED ON (B)(4) 2010 AND COLLECTED THE CUSTOMER'S CALIBRATIONS, AND COMPLETED INSPECTION. UPON REVIEW, IT WAS DETERMINED INSTRUMENT IS WORKING AND MEETS THE ISE (ION SELECTIVE ELECTRODES) GUIDELINES SET IN PLACE. NO REPAIR WAS PERFORMED. THE CUSTOMER WAS CONCERNED ABOUT CALIBRATIONS NOT HOLDING AND LOW SODIUM RESULTS. THE CUSTOMER SENT IN ABSORBANCE VS TIME CHARTS FOR ALL QUESTIONABLE SODIUM RESULTS TO BE REVIEWED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS SODIUM (NA) AND CHLORIDE (CL) RESULTS GENERATED BY UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. REPEAT TESTS WERE PERFORMED ON THE SAME AND/OR ON AN ALTERNATE INSTRUMENT. IT IS UNKNOWN IF PATIENT TREATMENT WAS AFFECTED IN THIS EVENT. THE RISK OF SERIOUS INJURY WILL BE ASSUMED UPON RECUR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other