BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 1890375 · Received November 3, 2010

    Report

    Report Number
    2050012-2010-01143
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC AND CALIBRATION RESULTS WERE ACCEPTABLE. THE CUSTOMER OBSERVED SUPPRESSED RESULTS FOR PHOSM. A BCI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE ON (B)(4) 2010. THE FSE CLEANED REAGENT LINE AND FLUSHED OUT WITH HOT DI WATER. THE FSE PRIMED THE ANALYZER, CALIBRATED, AND RAN CONTROLS SUCCESSFULLY. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO INCORRECT PHOSPHOROUS (PHOSM) RESULTS GENERATED BY UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING ON AN ALTERNATE ANALYZER PRODUCED DIFFERENT RESULTS. THE CUSTOMER INDICATED THE DIFFERENCES ARE NOT SIGNIFICANT ENOUGH TO REQUIRE AMENDING THE RESULTS. THE PATIENT TREATMENTS WERE NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1