BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1903981 · Received November 20, 2010

    Report

    Report Number
    2050012-2010-01322
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 29, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS 4+ LIPEMIC, OPAQUE BY VISUAL INSPECTION. QC PRIOR TO AND AFTER THE EVENT WAS WITHIN LAB'S ESTABLISHED RANGES. THE ISSUE WAS SAMPLE-SPECIFIC AND SERVICE WAS NOT APPLICABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THE OPERATOR OF THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM FAILED TO DILUTE OR ULTRACENTRIFUGE A 4+ LIPEMIC SAMPLE AND REPORTED A FALSE LOW SODIUM (NA) RESULT OF 120MMOL/L OUT OF THE LABORATORY. THE DAYSHIFT ULTRACENTRIFUGED THE SAMPLE AND RERAN THE ELECTROLYTES. THE NA RESULT WAS HIGHER (132MMOL/L) AND AMENDED. TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE FALSE NA RESULT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1