BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2042731 · Received April 6, 2011

    Report

    Report Number
    2050012-2011-00972
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, THE ISSUE STARTED ON (B)(6) 2011 AND UPON NOTICING MULTIPLE CALIBRATION FAILURES ON SOME TDM TESTS AND NOTICING LIQUID ON THE BLACK TRAY OF THE REAGENT CAROUSEL. CUSTOMER DRIED UP THE LIQUID ON THE REAGENT CAROUSEL TRAY AND LOADED NEW CHEMISTRY CARTRIDGES (CC); CALIBRATED AND RAN QC. QC READ IN RANGE FOR ALL CHEMISTRIES ON THE CC SIDE. A BCI FIELD SERVICE ENGINEER PERFORMED THE FOLLOWING: REPLACED REAGENT SYRINGE T-VALVE, A/B VALVE, AND BOTH WASH COLLAR VACUUM VALVES. REPLACED VACUUM PUMP DUE TO INTERMITTENT LOW VACUUM ERRORS. PRIMED X 20. THE CUSTOMER RAN FULL QC PANEL, & RESUMED OPERATION WITHOUT ERRORS OR LEAKS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO RECURRING REAGENT CAROUSEL TRAY LEAK ON THE UNICEL DXC 600I SYNCHRON CHEMISTRY ANALYZER. NO INJURY OR EXPOSURE TO BIOHAZARDOUS MATERIALS WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1