BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2283253 · Received October 7, 2011

    Report

    Report Number
    2050012-2011-06055
    Event Type
    Malfunction
    Date Received
    October 7, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING THE INSTALLATION OF THE UNICEL DXC 800 SYNCHRON SYSTEM, BECKMAN COULTER, INC. (BEC) FIELD SERVICE ENGINEER FOUND THAT AB REAGENT VALVE LEAKED DURING PRIMING DUE TO POOR SCREW OF THE CONNECTION PORT. THE FIELD SERVICE ENGINEER REPLACED THE AB REAGENT VALVE. PATIENT RESULTS HAVE NOT BEEN GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR TREATMENT.

    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. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1