BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 1951796 · Received January 6, 2011

    Report

    Report Number
    2050012-2011-00065
    Date Received
    January 6, 2011
    Date of Event
    December 12, 2010
    Report Date
    December 13, 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

    THE QC PRE AND POST THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. ON (B)(4) 2010 A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED THE FOLLOWING: ION-SELECTIVE ELECTRODE (ISE) MOD 10838, DECONTAMINATED THE SYSTEM, REPLACED TUBING, ELECTRODES AND ELECTROLYTE INJECTION CUP (EIC). SERVICE IS ON-GOING ON THE INSTRUMENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW SODIUM (NA) AND CARBON DIOXIDE (CO2) RESULT GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. FEW OF THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED AND ACCEPTABLE RESULTS WERE OBTAINED. AMENDED REPORTS WERE INITIATED. THE LAB HAS NOT RECEIVED ANY REPORTS OF IMPACT TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1