BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 3771915 · Received April 25, 2014

    Report

    Report Number
    2050012-2014-00210
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE EVALUATED THE INSTRUMENT AND CONFIRMED A LEAK COMING FROM REAGENT PROBE A OF THE INSTRUMENT. THE FSE PROCEEDED TO REPLACE THE REAGENT PROBE A COLLAR WASH VALVE TO RESOLVE THE LEAK. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBSERVING LIQUID ON THE REACTION WHEEL COVER OF THE UNICEL DXC 600 SYNCHRON SYSTEM. THE CUSTOMER ALSO STATED THAT AMMONIA QUALITY CONTROL (QC) RESULT WAS OUTSIDE OF THE ACCEPTABLE RANGE IN THE MORNING. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR DIRECT EXPOSURE TO THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251745 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1