BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 1951118 · Received January 6, 2011

    Report

    Report Number
    2050012-2011-00046
    Date Received
    January 6, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    2050012-01/11/2010-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRE THE EVENT WAS WITHIN LAB ESTABLISHED RANGES. UNKNOWN IF QC WAS RUN AFTER THE EVENT WAS RUN PRIOR TO RECALIBRATION. A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE FOLLOWING: NA AND NA REFERENCE ELECTRODES. ION-SELECTIVE ELECTRODE (ISE) REFERENCE REAGENT ON (B)(4) 2010. ISE BUFFER. FSE CHECKED REAGENT LINES, EIC, EIC VALVE AND RATIO PUMP. ALL WERE ACCEPTABLE. FSE ALSO VERIFIED UNIT PERFORMANCE WHICH WAS ACCEPTABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW SODIUM (NA) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED AND HIGHER RESULTS WERE OBTAINED. PATIENT'S TREATMENT WAS NOT IMPACTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1