BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 PRO SYNCHRON SYSTEM

    MDR report key: 4897077 · Received July 7, 2015

    Report

    Report Number
    2050012-2015-00262
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    June 19, 2015
    Report Date
    June 19, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K103842
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT AND CONFIRMED LEAKING/OVERFLOWING FROM THE EIC (ELECTROLYTE INJECTION CUP). THE FSE FOUND THE ISE (ION SELECTIVE ELECTRODE) WASTE COLLECTOR TUBING WAS LOOSE AND RESEATED THE TUBING TO RESOLVE THE LEAK ISSUE. THE BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK/OVERFLOW FROM THE EIC (ELECTROLYTE INJECTION CUP) ON THEIR UNICEL DXC 800 PRO SYNCHRON SYSTEM. THE CUSTOMER STATED THE LEAK WAS CONTAINED TO THE INSTRUMENT BUT WAS UNABLE TO DETERMINE THE VOLUME. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438342 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