BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® SYSTEM

    MDR report key: 3771921 · Received April 25, 2014

    Report

    Report Number
    2050012-2014-00211
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE IDENTIFIED AN OVERFLOW FROM THE PROBES DURING THE WASH CYCLE, WHICH LED TO THE CUVETTE OVERFLOW. THE FSE REPLACED THE WASTE LINE TUBING AND THE CUVETTE WASH TWO-WAY VALVE TO RESOLVE THE PROBE OVERFLOW. THERE WERE NO FURTHER LEAKS OR FAILED CUVETTE WATER BLANK TESTS REPORTED. (B)(4).

    Description of Event or Problem · 1

    WHILE ON SITE TO INVESTIGATE REPORTED FAILED CUVETTE WATER BLANK TESTS ON A UNICEL DXC 800 PRO SYNCHRON SYSTEM, A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) OBSERVED CUVETTE OVERFLOW ON THE INSTRUMENT DURING THE MAINTENANCE WASH CYCLE. THE OVERFLOW LEAK WAS CONTAINED TO THE INSTRUMENT. PERSONAL PROTECTIVE EQUIPMENT INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF DIRECT EXPOSURE TO THE LEAK OR OF INJURY IN CONNECTION WITH THE LEAK. ERRONEOUS RESULTS WERE NOT GENERATED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251747 UNICEL® DXC 800 PRO SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1