BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2251921 · Received September 16, 2011

    Report

    Report Number
    2050012-2011-04926
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE OBSERVED THAT THE EIC CUP WAS OVERFILLING. THE FSE INSTALLED NEW VALVES BUT THIS DID NOT RESOLVE THE ISSUE. THE FSE THEN REPLACED THE ENTIRE EIC ASSEMBLY AND RE-ALIGNED THE MODULAR CHEMISTRY SAMPLE ARM. THE FSE VERIFIED THE REPAIRS PER ESTABLISHED PROCEDURES THEN RECALIBRATED ALL OF THE MODULAR CHEMISTRY ASSAYS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT THAT THE EIC CUP WAS OVERFILLING WITH DEIONIZED WATER ON THEIR UNICEL DXC 800 SYNCHRON CHEMISTRY ANALYZER. THERE WAS NO IMPACT TO PATIENT SAMPLE ANALYSES OR TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER WAS ADVISED TO WEAR PERSONAL PROTECTIVE EQUIPMENT (PPE). THE CUSTOMER WAS ADVISED TO TRY CLEANING THE EIC PORTS BUT THIS DID NOT RESOLVE THE ISSUE. THERE WAS NO REPORT OF EXPOSURE TO THE CUSTOMER. NO INJURY WAS REPORTED. THERE WAS NO REPORT OF MEDICAL ATTENTION BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® CHEMISTRY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800

    Patients

    Seq Age Sex Outcome Treatment
    1