BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 1951093 · Received January 6, 2011

    Report

    Report Number
    2050012-2011-00036
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 11, 2010
    Report Date
    December 11, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER TO INSPECT THE REAGENT SYRINGE. THE CUSTOMER TIGHTENED THE LOOSE REAGENT SYRINGE; HOWEVER THE ISSUE WAS NOT RESOLVED. A BCI FIELD SERVICE ENGINEER (FSE) DISCOVERED THE AUTO-GLOSS WAS NOT REACHING THE BLADE AND REPAIRED THE ISSUE WITH NEW PERI TUBING. FSE DISCOVERED THE REAGENT PROBE B LEAK WAS CAUSED BY A FAULTY THREE WAY VALVE. FSE REPLACED THE VALVE WHICH RESOLVED THE ISSUE. FSE RAN QC AND CALIBRATION; BOTH PASSED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT A CARTRIDGE CHEMISTRY SAMPLE PROBE WAS STUCK IN SAMPLE TUBE. DURING TROUBLESHOOTING THE CUSTOMER NOTICED REAGENT PROBE LEAKING. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON ® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1