BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2344765 · Received November 22, 2011

    Report

    Report Number
    2122870-2011-05544
    Event Type
    Malfunction
    Date Received
    November 22, 2011
    Date of Event
    November 3, 2011
    Report Date
    November 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER INC. SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 IN CONJUNCTION WITH THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) VERIFIED INSTRUMENT ASPIRATION, MAIN PIPETTOR ULTRASONIC VOLTAGE AND SYSTEM VACUUM WITH ACCEPTABLE RESULTS. THE FSE PERFORMED PREVENTIVE MAINTENANCE ACTIVITIES ON THE INSTRUMENT. THE FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK WHICH FAILED TO MEET SPECIFICATIONS. THE FSE REPLACED THE WASH CAROUSEL BEARINGS AND REBUILT BOTH THE WASH PUMP AND PRECISION PUMP. THE FSE NOTICED A LEAK WITHIN THE WASH MANIFOLD EXITING AT THE VALVE HOME SENSOR SO THE VALVE MANIFOLD WAS REPLACED. SUBSEQUENTLY, THE FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK WHICH MET SPECIFICATIONS. AFTER THE COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. ASSOCIATED MDRS: 2122870-2011-05543, 2122870-2011-05619, 2122870-2011-05620, 2122870-2011-05621, 2122870-2011-05544.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT HIGHER THAN EXPECTED CARDIAC TROPONIN (ACCUTNI) RESULTS WERE GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR MULTIPLE PATIENT SAMPLES ACROSS FIVE DAYS. THIS REPORT IS TWO OF FIVE AND REPRESENTS THE HIGHER THAN EXPECTED ACCUTNI RESULT GENERATED ON AN UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PATIENT ON (B)(6) 2011. THE INITIAL ACCUTNI RESULT WAS ELEVATED AND WITHIN THE RISK STRATIFICATION RANGE. THE INITIAL ELEVATED ACCUTNI RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND WHILE THERE WERE NO REPORTS OF ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNKNOWN AS TO WHETHER THERE WAS A CHANGE TO PATIENT MANAGEMENT. SUBSEQUENT TESTING ON AN ALTERNATE INSTRUMENT PRODUCED A LOWER RESULT WITHIN THE RISK STRATIFICATION BUT OUTSIDE THE ASSAY'S STATED PRECISION CLAIM. BECKMAN COULTER INC. ASSESSMENT OF SUPPLIED DATA INDICATED THAT BOTH LEVELS OF ACCUTNI QUALITY CONTROL HAD BEEN PERFORMING WITHIN THE CUSTOMER'S ESTABLISHED RANGES FOR THE PAST 30 DAYS. INSTRUMENT ROUTINE SYSTEM CHECKS PERFORMED DURING THE TIMEFRAME OF THE EVENT GENERATED RESULTS WITHIN INSTRUMENT SPECIFICATIONS. THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN PLASMA TUBE AND WAS CENTRIFUGED PRIOR TO TESTING. TESTING WAS DONE FROM THE PRIMARY TUBE. SPECIFIC PATIENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS ACCUTNI - REAGENT