BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2880680 · Received December 20, 2012

    Report

    Report Number
    2050012-2012-01925
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 22, 2012
    Report Date
    November 22, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND EVALUATED THE SYSTEM. THE FSE FOUND THE DRAIN WAS FULL. UPON FURTHER EXAMINATION, THE FSE FOUND THE DRAIN VALVE WAS OCCLUDED WITH UNSPECIFIED SOLID MATERIAL. THE FSE CLEARED THE OBSTRUCTION. THE REPAIR WAS VERIFIED BY ESTABLISHED PROCEDURES AND THE INSTRUMENT IS OPERATING WITHIN PUBLISHED SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. THAT THERE WAS A LEAK FROM THE ION-SELECTIVE ELECTRODE (ISE) AREA OF THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. NO ERRONEOUS RESULTS WERE GENERATED. THE LEAK WAS CONTAINED TO THE INSTRUMENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE EVENT. THERE ARE NO REPORTS OF ANY ADVERSE EVENTS. A BECKMAN COULTER FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE TO EVALUATE THE SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1