BEUDAMED
    FDA Adverse Event Summary report: N

    SYNCHRON UNICEL DXC 600

    MDR report key: 1971239 · Received January 26, 2011

    Report

    Report Number
    2050012-2011-00213
    Date Received
    January 26, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC IS RUN TWICE A DAY. THE QC WAS OUT >4SD, THE CUSTOMER RECALIBRATED AND RE-RAN THE QC WITH ACCEPTABLE RESULTS. THE CUSTOMER FOUND CRYSTALS IN THE REAGENT WHILE TROUBLESHOOTING. THE CUSTOMER DISCARDED AND LOADED A FRESH REAGENT. A BCI FIELD SERVICE ENGINEER (FSE) CLEANED ALL REAGENT LINES LEADING TO AND FROM THE GLUCOSE MODULE. FSE DETERMINED THE CRYSTALS AS THE POTENTIAL ROOT CAUSE, AS THEY CLOGGED REAGENT TUBING LINES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO FIVE (5) ERRONEOUS HIGH GLUCOSE (GLUM) RESULTS GENERATED BY SYNCHRON UNICEL DXC 600 CLINICAL CHEMISTRY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED ON THE SAME UNIT LOWER RESULTS WERE OBTAINED. AMENDED REPORTS WERE INITIATED. LABORATORY PATHOLOGIST CONFIRMED PATIENT TREATMENT WAS NOT WITHHELD OR ADMINISTERED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON UNICEL DXC 600 CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC600 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1