BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1200382 · Received October 15, 2008

    Report

    Report Number
    2122870-2008-00318
    Event Type
    Other
    Date Received
    October 15, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 15, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS LI HEPARIN PLASMA, APPEARED CLEAR AND WAS CENTRIFUGED AT 3000 G FOR 15 MINUTES AT 20 C. A SYSTEM CHECK WAS PERFORMED ON 09/22/2008 AND PASSED ALL PORTIONS. EVENT LOG SHOWS NO WARNINGS OR EVENTS THAT OCCURRED AROUND THE TIME THE PATIENT SAMPLE WAS RUN. QC DATA WAS PROVIDED UP THROUGH 09/22/2008. ALL LEVELS WERE RECOVERING WITHIN THE CUSTOMERS EXPECTED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS ONSITE 09/25/2008: CUSTOMER STATED TO FSE THAT AT SOME POINT MAINTENANCE WAS DONE IMPROPERLY AND ONE OF THE ASPIRATE PROBES WAS NOT REPLACED CORRECTLY. WASH BUFFER WAS SPILLED INTO THE ANALYTICAL UNIT AND DRIED LEAVING A WHITE SALT RESIDUE THAT COULD HAVE FALLEN INTO A REACTION VESSEL DURING WASHING. FSE REPLACED THE MIXER PULLEY THAT HAD BECOME CORRODED FROM WASH BUFFER AND THOROUGHLY CLEANED THE ANALYTICAL UNIT. FSE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES. RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT. (B) (4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUSLY ELEVATED ACCUTNI RESULT PRODUCED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PATIENT. CUSTOMER TESTED A PATIENT SAMPLE FOR ACCUTNI AND OBTAINED A RESULT OF 30.43NG/ML WHICH REPEATED AT 0.03NG/ML. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THERE WAS NO 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 CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA