BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2883610 · Received December 21, 2012

    Report

    Report Number
    2050012-2012-01940
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER VISITED THE SITE AND EXAMINED THE SYSTEM. THE ENGINEER REMOVED AND EXAMINED ALL CARTRIDGES; NO DEFECTS WERE FOUND. ALL CARTRIDGE CHEMISTRY PROBES WERE PRIMED; NO LEAKING WAS OBSERVED. SUBSEQUENTLY, THE FSE RETURNED TO THE SITE AND FOUND NO WIPER IN THE WASH TOWER ASSEMBLY. THE INSTRUMENT WAS REPAIRED. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER THAT THE CARTRIDGE CHEMISTRY REAGENT PROBES WERE LEAKING ON THEIR UNICEL DXC 800 SYNCHRON SYSTEM. THE CUSTOMER OBSERVED FLUID ON THE CARTRIDGE AND BOTTOM TRAY. ERRONEOUS RESULTS WERE GENERATED FOR ONE PATIENT SAMPLE. THE SAMPLE WAS RETESTED AND CORRECTED RESULTS WERE OBTAINED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE 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