BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 PRO SYNCHRON SYSTEM

    MDR report key: 3885253 · Received June 19, 2014

    Report

    Report Number
    2050012-2014-00293
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 24, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND DISCOVERED A LEAK FROM THE WASH/VACUUM PROBE. THE FSE INDICATED THAT THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT AND PROCEEDED TO CLEAN THE LEAK. THE FSE DETERMINED THAT THE CAUSE OF THE LEAK FROM THE WASH PROBE AND THE FAILING WATER BLANK ERRORS IS ATTRIBUTED TO THE REAGENT BEAD BEING LODGED IN THE WASH/VACUUM PROBE. THE FSE REMOVED THE REAGENT BEAD FROM THE PROBE TO RESOLVE THE ISSUES AND NO FURTHER LEAKS OR ERROR MESSAGES WERE OBSERVED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNICEL DXC 600 PRO SYNCHRON SYSTEM GENERATED FAILING WATER BLANK ERRORS. CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE TELEPHONE BUT THE ISSUE WAS NOT RESOLVED AND A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY. ERRONEOUS RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361529 UNICEL DXC 600 PRO SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1