BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2140276 · Received June 27, 2011

    Report

    Report Number
    2050012-2011-02648
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CTS ASSISTED THE CUSTOMER IN TROUBLESHOOTING AND FOUND THAT THE REAGENT SYRINGE WAS LOOSE AND FLUID HAD PUDDLED ON THE REAGENT TRAY. CTS DIRECTED THE CUSTOMER TO RESEAT THE SYRINGE BARREL AND CLEAN LIQUID. CTS DIRECTED CUSTOMER TO CHECK THE MIXER PADDLES AND THE CUSTOMER DISCOVERED THE REAGENT PADDLE WAS MISSING; CUSTOMER DID NOT HAVE A SPARE. A BCI FIELD SERVICE ENGINEER (FSE) FOUND REAGENT PROBE LEAKING AND CUVETTE NOT DRY BEFORE REAGENT INJECT. FSE UPDATED CHEMISTRY SOFTWARE FOR CUSTOMER AND RAN CONTROLS. REPAIRS VERIFIED PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) CUSTOMER TECHNICAL SUPPORT (CTS) TO REPORT FLUID LEAK FROM THE REAGENT PROBE. NO INJURY WAS REPORTED OR OCCURRED DUE TO THIS EVENT.

    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