BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 2240206 · Received September 9, 2011

    Report

    Report Number
    2050012-2011-05089
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE INSPECTING THE INSTRUMENT WITH BEC CTS (CUSTOMER TECHNICAL SUPPORT), THE CUSTOMER ALSO FOUND LIQUID ON TOP OF THE CARTRIDGE CHEMISTRY (CC) CUVETTE COVER. CTS GENERATED A SERVICE REQUEST. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND PERFORMED SERVICE ON THE INSTRUMENT. FSE REPLACED REAGENT PROBE A VACUUM WASTE VALVE, 4-WAY VALVE, AND WASH COLLAR; PROBE A ALIGNMENT WAS PERFORMED AND INSTRUMENT WAS PRIMED TO VERIFY FUNCTION. THE CUSTOMER ATTEMPTED TO USE THE INSTRUMENT IMMEDIATELY FOLLOWING THE REPAIRS BUT WAS GETTING "CUVETTE NOT DRY AT REAGENT INJECT" ERROR AS WELL AS OTHER ERRORS RELATED TO REAGENT PROBES AND REAGENT PICKUP. FSE INSPECTED THE INSTRUMENT AND FOUND FLUID REMAINING IN CUVETTE PRIOR TO TEST AND IRON CHEMISTRY WOULD NOT PASS DUE TO SUPPRESSED ERROR. FSE REPLACED REAGENT PROBES AND COMPLETED REAGENT PROBE B WASH COLLAR AND PROBE ALIGNMENT. FSE COMPLETED SEVERAL TESTS TO VERIFY INSTRUMENT FUNCTION SUCH AS CARRYOVER TEST, CUVETTE DRYNESS TEST AND PRECISION ACCURACY TEST AND NO ISSUES WERE NOTED. QC WAS TESTED AND CALIBRATION WAS PERFORMED TO VERIFY REPAIR. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. THE BEC INTERNAL IDENTIFIER FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THEY NOTICED FLUID UNDERNEATH THE REAGENT DRIP TRAY WHILE PERFORMING MAINTENANCE ON THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. NO INJURY OR EXPOSURE WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1