BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1963104 · Received January 18, 2011

    Report

    Report Number
    2050012-2011-00139
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2010 FOR THIS EVENT. THE FSE CHECKED THE EIC CUP AND CLEANED DEBRIS IN ONE PORT AND REINSTALLED. THE FSE INSTALLED VALVE ASSEMBLY. THE FSE ALSO REMOVED AND CHECKED LINES AND PRIMED THE UNIT WITH NO OVERFLOW. THE FSE PERFORMED CALIBRATION AND RAN PRECISION, RESULTING WITHIN ACCEPTABLE RANGE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE ELECTROLYTE INJECTION CUP (EIC) WAS LEAKING FLUID INTO THE ISE COMPARTMENT. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1