BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1364045 · Received January 16, 2009

    Report

    Report Number
    2122870-2009-00009
    Event Type
    Other
    Date Received
    January 16, 2009
    Date of Event
    December 24, 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
    MI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES ARE COLLECTED IN PLASTIC BD LITHIUM HEPARIN TUBES WITH GEL AND ARE CENTRIFUGED AT 3500 RPM FOR 10 MINUTES AT ROOM TEMPERATURE IN A SWINGLE BUCKET CENTRIFUGE. QC RESULTED WITHIN SPECIFICATIONS PRIOR TO AND AFTER THE EVENT. A SYSTEM CHECK PERFORMED ON (B)(6) 2008, RESULTED WITHIN SPECIFICATIONS. A SYSTEM CHECK PERFORMED ON (B)(6) 2008, AT 12:44 PM, FAILED THE WASHED PORTION DUE TO QNS FLAGS. THE SYSTEM CHECK WAS REPEATED ON (B)(6) 2008, AT 8:02 PM, AND MET SPECIFICATIONS. NO EVENTS WERE POSTED TO THE EVENT LOG DURING THE TIME OF THE EVENT, PER THE CUSTOMER. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(6) 2008: FSE COMPLETED INSTRUMENT HARDWARE EVALUATION. FSE NOTED ASPIRATE PROBE WAS DIRTY. FSE COMPLETED VOLUME CHECKS AND NOTED A LARGE NUMBER OF BUBBLES IN THE REACTION VESSELS. FSE REMOVED AND REBUILT THE WASH PUMP INCLUDING THE BELT. FSE VERIFIED ALL VOLUME CHECKS WHICH PASSED WITH NO ERRORS. FSE PERFORMED SYSTEM CHECK AND DIAGNOSTIC TESTING WHICH BOTH MET SPECIFICATIONS. FSE VERIFIED QC AND VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. PER FSE UPDATE ON 1/7/2009 - FSE STATED HE BELIEVED THE REBUILDING OF THE WASH PUMP RESOLVED THE CUSTOMER'S ACCUTNI RESULT ISSUES. THE VOLUME CHECK TESTING PERFORMED AFTER THE WASH PUMP WAS REBUILT MET SPECIFICATIONS AND NO BUBBLES WERE PRESENT. ALTHOUGH HARDWARE ISSUES ADDRESSED BY THE FSE 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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY ELEVATED ACCUTNI RESULTS GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR MULTIPLE PATIENTS. CUSTOMER TESTED 7 PATIENT SAMPLES FOR ACCUTNI AND OBTAINED RESULTS IN THE RANGE OF 0.15-1.12NG/ML AND UPON REPEAT, RESULTS IN THE RANGE OF 0/05-7.88 WERE OBTAINED. THE ELEVATED ACCUTNI PATIENT RESULTS DID NOT MATCH THE CLINICAL PICTURES OR PAST MEDICAL HISTORIES OF THE PATIENTS AND THEREFORE, SOME SAMPLES WERE REPEATED ON A DIFFERENT INSTRUMENT AND RESULTS WERE IN THE RANGE 0.02-0.10NG/ML. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF 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 DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. DXC 600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA