BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2227789 · Received August 30, 2011

    Report

    Report Number
    2050012-2011-04794
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPLACED SAMPLE PROBE ON (B)(4) 2011 BUT THE LEAK CONTINUED. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND FOUND THAT LEAK WAS FROM THE MC PROBE COLLAR WASH DUE TO CLOT INSIDE VACUUM VALVE. FSE OPENED AND CLEANED THE VALVE ASSEMBLY. THIS RESOLVED THE ISSUE. FSE PRIMED AND CALIBRATED ALL MC CHEMISTRIES WITH NO ERRORS AND RAN QC. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT THE MODULAR CHEMISTRY (MC) SAMPLE PROBE IN THE UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM WAS LEAKING. 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 SYNCHRON® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1