BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2233799 · Received September 4, 2011

    Report

    Report Number
    2050012-2011-05079
    Event Type
    Malfunction
    Date Received
    September 4, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BEC FIELD SERVICE ENGINEER (FSE) PERFORMED SERVICE ON THE INSTRUMENT: SERVICE HAD BEEN PERFORMED, PER THE CUSTOMER, FOR 1 REAGENT PROBE LEAKING AND CUVETTE NOT DRY ERRORS. FSE REPLACED THE SYRINGE BARREL AND THE 3 WAY VALVE. FSE REPLACED THE T-VALVE TO ADDRESS THE LEAKING. FSE DETERMINED THE CUVETTE NOT DRY ERRORS WERE DUE TO A PLUGGED WASH TOWER PROBE; THE CUSTOMER REPLACED THIS PART. NO FURTHER REPORTS OF LEAKING AND/OR RELATED ERRORS NOTED IN ORACLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) CUSTOMER TECHNICAL SUPPORT TO REPORT BOTH REAGENT PROBES LEAKED ON THE UNICEL DXC 600I SYNCHRON CHEMISTRY ANALYZER. CUSTOMER STATED THE FITTINGS ON TOP OF THE REAGENT PROBES ARE TIGHT. NO INJURY OR EXPOSURE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1