BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2213675 · Received August 16, 2011

    Report

    Report Number
    2050012-2011-04532
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 17, 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THEY COMPLETED THE EIC CLEANING PROCEDURE BUT IT CONTINUED TO OVERFLOW. . THE CUSTOMER TRIED RESEATING THE CONNECTIONS TO THE SOLENOID, AND SHUTDOWN THE INSTRUMENT, BUT EIC CONTINUED TO OVERFLOW. SERVICE WAS PERFORMED ON THIS INSTRUMENT ON (B)(6) 2011. THE FIELD SERVICE ENGINEER (FSE) NOTED THAT THE ISE (ION SELECTIVE ELECTRODE) WAS DISABLED WHEN HE ARRIVED AT THE LABORATORY. THE FSE ENABLED ISE WITHOUT ANY ERRORS AND PRIMED 30 TIMES. NO ERRORS OR FLOODING WERE OBSERVED DURING PRIMING. THE FSE CLEANED EIC AND FLOW CELL. THE FSE CHECKED EIC VALVES, BUT NO PROBLEM WAS NOTED. CALIBRATION WAS PERFORMED AND QC PASSED THE SPECIFICATIONS. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. THE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) AND REPORTED THAT THE EIC (ELECTROLYTE INJECTION CUP) ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM WAS OVERFLOWING. THE CUSTOMER PICKED A BLIND PATIENT SAMPLE AND VERIFIED THAT THE RESULT WAS NOT AFFECTED. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION AND THERE WAS NO EFFECT TO PATIENT OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1