BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2100021 · Received May 24, 2011

    Report

    Report Number
    2050012-2011-01883
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 23, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS IN A CLOSED TUBE. QC WAS WITHIN ESTABLISHED RANGES. A BCI FIELD SERVICE ENGINEER (FSE) INSPECTED THE UNIT AND DETERMINED THAT THE AUTOGLOSS WAS NOT BEING DELIVERED PROPERLY AND TUBE NUMBER 301 WAS PINCHED. FSE REPLACED THE TUBE ACCORDINGLY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW UREA NITROGEN (BUN) AND CREATININE (CR-S) RESULTS ON ONE PATIENT SAMPLE GENERATED THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED AND HIGHER RESULTS WERE OBTAINED AND AMENDED RESULTS WERE REPORTED. NO CHANGE TO PATIENT TREATMENT OR DIAGNOSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1