BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2110837 · Received June 2, 2011

    Report

    Report Number
    2050012-2011-02096
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT (CTS) INSTRUCTED THE CUSTOMER TO TAKE LINE 36 OFF AND OBSERVED FLUID COMING OUT OF THE DRAIN PORT. NO OBSTRUCTION WAS NOTED. CTS HAD CUSTOMER PRIME AND IT'S STILL FILLING UP DRAIN.(B)(4) A BCI FIELD SERVICE ENGINEER (BCI) FOUND J2 VALVE ON ISE DRAIN ASSEMBLY NOT WORKING. FSE SHUT DOWN AND RESTARTED THE INSTRUMENT; HOWEVER, THE VALVE WAS STILL NOT OPERATIONAL. FSE REPLACED J2 ON VALVE ASSEMBLY, PRIMED ISE, CALIBRATED ISE AND RAN QC. THIS ISSUE HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT GETTING A CAL REFERENCE DRIFTS AND THE FLOW CELL DRAIN OVERFLOWED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1