BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1055428 · Received May 28, 2008

    Report

    Report Number
    2122870-2008-00159
    Event Type
    Other
    Date Received
    May 28, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 28, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS PLASMA. QC IS RUN DAILY AND WAS WITHIN SPECIFICATIONS. THERE WERE NO ERRORS IN THE EVENT LOG. SYSTEM CHECK PERFORMED IN 2008 AT 9:44 PM PASSED WITHIN SPECIFICATIONS. CUSTOMER REPEATED ALL SAMPLES BACK TO THE LAST ACCEPTABLE QC. CUSTOMER IS NOT QUESTIONING ANY OTHER ASSAYS OR RESULTS: A FIELD SERVICE ENGINEER (FSE) WAS ON SITE THE NEXT DAY: THE FSE DISCOVERED A LARGE AMOUNT OF MICRO BUBBLES IN THE WASH PUMP INTERMITTENTLY. THE FSE CLEANED THE WASH VALVE AND REPLACED THE WASH PUMP SEAL AND O-RING. MICRO BUBBLES STILL OCCURRED. THE FSE REBUILT THE WASH VALVE ASSEMBLY AND REPLACED DISPENSE PROBES. ALL VERIFICATION TESTING PASSED PER ESTABLISHED PROCEDURES. 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 PT. CUSTOMER TESTED A SAMPLE FOR ACCUTNI AND OBTAINED A RESULT OF 1.54 NG/ML WHICH REPEATED AT 0.03 NG/ML. WHEN TESTED AT A LATER TIME, THIS SAMPLE GAVE A RESULT OF 0.08 NG/ML AND UPON TESTING ON A DIFFERENT INSTRUMENT, IT GAVE A RESULT OF 0.03 NG/ML. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LAB AND A CORRECTED REPORT WAS SUBMITTED. THE CUSTOMER HAS NOT RECEIVED A REPORT OF PT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA