BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM (PACKAGED)

    MDR report key: 2091519 · Received May 17, 2011

    Report

    Report Number
    2050012-2011-01585
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER USED PPE TO CLEAN THE LEAK, BUT THE INSTRUMENT CONTINUED TO LEAK. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND FOUND A LINE ON RATIO PUMP HAD POPPED OFF AND WAS GETTING CAUGHT AND PINCHED IN THE ISE DRAWER. FSE REMOVED AND REROUTED THE TUBE WHICH RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THE HYDRO PAN IN THE UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM WAS LEAKING UNDER BULK REAGENTS. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM (PACKAGED) CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1