BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2163020 · Received July 15, 2011

    Report

    Report Number
    2050012-2011-03098
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 12, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND THAT THE CLOT/OBSTRUCTION DETECTOR (ODC) FOR THE MC PROBE HAD A RUPTURED DIAPHRAGM. THE FSE REPLACED THE ODC ASSEMBLY, THEN CALIBRATED THE ODC, AND TESTED THE CIRCUIT. THE FSE ALSO CALIBRATED AND RAN QC ON THE SYSTEM AND ALL RESULTS PASSED WITHIN SPECIFICATIONS. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THERE WAS A FLUID LEAK FROM THE MODULAR CARTRIDGE (MC) SAMPLE PROBE TRANSDUCER IN THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER INDICATED THAT THE LEAK OCCURRED AFTER REPLACING THE SAMPLE PROBE DUE TO AN MC PROBE OBSTRUCTION. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED IN THIS EVENT.

    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