BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM

    MDR report key: 2358960 · Received December 5, 2011

    Report

    Report Number
    2122870-2011-05621
    Event Type
    Malfunction
    Date Received
    December 5, 2011
    Date of Event
    November 5, 2011
    Report Date
    November 5, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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, 2122870-2011-05544.

    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 FIVE OF FIVE AND REPRESENTS THE HIGHER THAN EXPECTED ACCUTNI RESULT GENERATED ON AN UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR THREE PATIENTS 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 NORMAL RANGE FOR ALL THREE OF THE PATIENTS. 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 FOR TEN MINUTES AT 3000 RPM. TESTING WAS DONE FROM THE PRIMARY TUBE THROUGH THE CLOSE TUBE ACCESSION. SPECIFIC PATIENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER INC. DXC 600I 800215

    Patients

    Seq Age Sex Outcome Treatment
    1