BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2091505 · Received May 17, 2011

    Report

    Report Number
    2050012-2011-01583
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND NOTED THAT CUSTOMER HAD CORRECTED THE LEAK. THE CUSTOMER HAD UNINTENTIONALLY OVERFLOWED THE NO-FOAM BOTTLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FLUID NOTICED ON THE HYDRO PAN AND BEHIND THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE CUSTOMER WAS UNABLE TO IDENTIFY THE SOURCE OF THE LEAK. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1