BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 1998996 · Received February 23, 2011

    Report

    Report Number
    2050012-2011-00500
    Event Type
    Malfunction
    Date Received
    February 23, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE QC PRIOR TO AND AFTER THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. A BCI FIELD SERVICE ENGINEER (FSE) FOUND A BROKEN ELECTROLYTE INJECTION CUP (EIC) VALVE AND FAULTY EIC QUAD RING. FSE REPLACED THE EIC ASSEMBLY AND THE EIC QUAD RING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW SODIUM (NA) RESULTS ON THREE PATIENTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED AND HIGHER RESULTS WERE OBTAINED. AMENDED REPORTS WERE INITIATED. PATIENT TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE FALSE RESULTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1