BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2042783 · Received April 7, 2011

    Report

    Report Number
    2050012-2011-00974
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CGA
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC HAD BEEN DRIFTING THE PAST 4 HOURS DURING THE EVENT TIME BUT WAS WITHIN THE ESTABLISHED 1 SD RANGE. BCI TRIED TO OBTAIN THE INSTRUMENT'S AVT PLOTS FOR BOTH THE ORIGINAL AND RERUN OF THE SAMPLE ON THE INSTRUMENT IN QUESTION BUT THE CUSTOMER HAD CLEARED THE SAMPLE DATABASE. SERVICE WAS NOT REQUESTED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ONE DISCREPANT GLUCOSE (GLU) RESULT THAT WAS NOTICED WHEN RUNNING IN DUPLICATE MODE ON THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE ORIGINAL RESULT WAS 68MG/DL AND THE RERUN RESULT WAS 81MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND A RESULT OF 78 AND 80MG/DL WAS OBTAINED. NO ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO AFFECT TO PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER CGA BECKMAN COULTER INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1