BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 1981759 · Received February 8, 2011

    Report

    Report Number
    2050012-2011-00389
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 9, 2011
    Report Date
    January 10, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN BEFORE THE EVENT AND THE RESULTS WERE WITHIN THE ESTABLISHED RANGES. CALIBRATION WAS REPEATED THRICE THE NIGHT PRIOR TO THE EVENT TO BEING QC INTO RANGE. POST DELTA CHECK, THE CUSTOMER RECALIBRATED AND RAN QC AND REPEATED THE PATIENT SAMPLES. A BCI FIELD SERVICE ENGINEER (FSE) CLEANED THE FLOW CELL AND FOUND SAMPLE SYRINGE GRINDING. FSE REPLACED THE BEARING, MODULAR CHEMISTRY AND CHEMISTRY CARTRIDGE SYRINGE DRIVES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO FOUR ERRONEOUS LOW CARBON DIOXIDE (CO2) RESULTS, WHICH WERE DETECTED THROUGH DELTA CHECK, GENERATED ON THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY; HENCE NO PATIENT TREATMENT WAS IMPACTED BY THE EVENT. THE SAMPLES WERE REPEATED POST RECALIBRATION AND QC RAN ON THE INSTRUMENT HIGHER RESULTS WITHIN NORMAL RANGE WERE OBTAINED AND REPORTED.

    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. DXC600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1