BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1364050 · Received January 16, 2009

    Report

    Report Number
    2122870-2009-00006
    Event Type
    Other
    Date Received
    January 16, 2009
    Date of Event
    December 29, 2008
    Report Date
    January 16, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE IS PLASMA FROM A LI HEPARIN TUBE AND CENTRIFUGED FOR 5 MINUTES. THE INSTRUMENT IS PROGRAMMED TO AUTOMATICALLY REPEAT ALL ACCUTNI RESULTS ABOVE CUSTOMER'S SET CUTOFF. CUSTOMER NOTICED THE ACCUTNI RESULTS WERE NOT REPEATING AND RAN QC WHICH WAS WITHIN SPECIFICATIONS. CUSTOMER SUPPORT HOTLINE HAD THE CUSTOMER RUN A DIAGNOSTIC SYSTEM CHECK. THIS PASSED SPECIFICATIONS, HOWEVER, ONE PARAMETER WAS AT THE HIGHER SPECIFICATIONS LIMITS. THE CUSTOMER TRIED CALIBRATING ACCUTNI AND RECEIVED WASH VALVE/PUMP MOTION ERRORS. THE CUSTOMER SUPPORT HOTLINE TALKED THE CUSTOMER THROUGH CLEANING THE WASH VALVE AND INSTRUCTED THEM TO PERFORM ANOTHER SYSTEM CHECK TO VERIFY THE SYSTEM. THE SYSTEM CHECK FAILED WITH A QNS FLAG ON THE FIRST CUP. A FIELD SERVICE ENGINEER (FSE) WAS ON SITE IN 2009: FSE FOUND THAT ASPIRATE PROBE TUBING WAS ROUTED THROUGH A WIRING HARNESS. FSE REPLACED THE INTERNAL SEAL ON THE WASH PUMP AND THE INTERNAL SEAL OF THE WASH VALVE, ALONG WITH REPLACING THE TIMING BELT OF THE WASH PUMP. SYSTEM CHECK AND QC WERE ALL WITHIN SPECIFICATIONS. ALTHOUGH HARDWARE ISSUES MAY HAVE CONTRIBUTED TO THIS EVENT, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE, A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUSLY ELEVATED ACCUTNI RESULT GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PATIENT. CUSTOMER TESTED A SAMPLE FOR ACCUTNI AND OBTAINED A RESULT OF 0.63NG/ML. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. IT IS UNKNOWN IF THERE WAS AN AFFECT TO PATIENT OR USER WITH REGARDS TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. DXC 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA