BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2880681 · Received December 20, 2012

    Report

    Report Number
    2050012-2012-01924
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 ENGINEER IDENTIFIED THE CAUSE OF THE EVENT AS INSUFFICIENT VACUUM. THE ENGINEER REMOVED AND REPLACED THE MAIN VACUUM PUMP. THE ISSUE WAS RESOLVED. THE REPAIR WAS VERIFIED ACCORDING TO ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER THAT THE UNICEL DXC 800 SYNCHRON SYSTEM CARTRIDGE CHEMISTRY REAGENT PROBE B IS LEAKING. THE LEAK WAS CONTAINED TO THE INSTRUMENT. NO ERRONEOUS RESULTS WERE GENERATED. THERE ARE NO REPORTS OF ANY ADVERSE EVENTS. THERE WERE NO REPORTS OF ANY INJURIES OR EXPOSURES TO ANY LABORATORY PERSONNEL. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1