BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2063544 · Received April 19, 2011

    Report

    Report Number
    2050012-2011-01145
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. THE FSE REPLACED THE MEASURE NA ELECTRODE AND CARBON BRIDGE AND PERFORMED SERUM FLASH OF FLOW CELL. HOWEVER, THE PROBLEM WAS NOT FIXED AND THE ISE WAS DISABLED. THE FSE RETURNED TO THE CUSTOMER LAB ON (B)(6) 2011, AND REPLACED BOTH NA ELECTRODES, BUT STILL OBSERVED HIGH RESULTS. THE FSE REPLACED ELECTROLYTE INJECTION CUP SPACER AND WASHER, PERFORMED MC PROBE VERTICAL ALIGNMENTS, REPLACED CARBON BRIDGE, AND PERFORMED FLOW CELL CONDITIONING WITH SERUM. THE FSE PERFORMED CALIBRATION AND VERIFICATION ASSESSMENT, AND BOTH TESTS PASSED. PER THE FSE, HE WAS NOT ABLE TO REPRODUCE THE LEAK OR IDENTIFY THE SOURCE. ALTHOUGH THE FSE REPLACED PARTS AND SERVICED THE INSTRUMENT, ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) AND REPORTED THAT THE MODULAR CHEMISTRIES (CC) SAMPLE PROBE IS LEAKING AND ELECTROLYTES WOULD NOT CALIBRATE ON UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. NO INJURY WAS REPORTED ON THIS ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1