BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 1951794 · Received January 6, 2011

    Report

    Report Number
    2050012-2011-00042
    Date Received
    January 6, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES; HOWEVER IT WAS REPEATED DUE TO PREVIOUS LOW QC RESULT. ON (B)(4) 2010 A BCI FIELD SERVICE ENGINEER (FSE) REMOVED A FIBRIN CLOT FROM THE INSIDE OF THE FLOW-CELL AND VERIFIED SYSTEM PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW SODIUM (NA) RESULT GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE ISSUE WAS DISCOVERED DUE TO THE ANION GAP BEING LOW. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED ON AN ALTERNATE INSTRUMENT AND HIGHER RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    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