BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 3834068 · Received May 27, 2014

    Report

    Report Number
    2122870-2014-00406
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED AIR BUBBLES IN THE WASH PUMP DURING THE PIPETTOR PRIME CYCLE. THE FSE NOTICED THE WASH STATOR WAS NOT SEATED CORRECTLY AND CLEANED THE WASH VALVE COMPONENTS AND RESEATED THE WASH STATOR CORRECTLY. THE FSE VERIFIED THE MIXER SPEED, REAGENT PACK ALIGNMENTS, AND ULTRASONIC SETTINGS; NO ISSUES WERE NOTED. THE FSE PERFORMED ROUTINE SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK; BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE CUSTOMER THEN PERFORMED ASSAY QUALITY CONTROL (QC) WHICH PASSED WITHIN THE LABORATORY'S ESTABLISHED RANGES. THE FSE NOTED BUBBLES WERE STILL IN THE WASH PUMP AND REPLACED THE O-RINGS FOR THE WASH PUMP AND PRECISION PUMP AS WELL AS REPLACED THE FLUIDICS MANIFOLD. THE FSE THEN DISCOVERED THAT THE PRECISION VALVE CAP WAS NOT SEATED PROPERLY. THE FSE SWITCHED THE WASH VALVE CAP WITH THE PRECISION VALVE CAP AND NOTED THEY WERE SEATED CORRECTLY. NO FURTHER AIR BUBBLES WERE NOTED IN THE PUMPS/TUBING/CHANNELS AT THIS TIME. THE FSE RETURNED WITH PARTS ORDERED, ON (B)(4) 2014, AND NOTED THERE WERE STILL BUBBLES IN THE WASH PUMP AFTER THE INITIAL PRIME. THE FSE REPLACED THE MANIFOLD/VALVE ASSEMBLY AND THE WASH PUMP. THE FSE PERFORMED 10 CYCLES OF PIPETTOR PRIMING DID NOT OBSERVE ANY EVIDENCE OF AIR BUBBLES IN THE WASH PUMP. THE FSE PERFORMED ROUTINE SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK; BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE CUSTOMER THEN PERFORMED ASSAY QC WHICH PASSED WITHIN THE LABORATORY'S ESTABLISHED RANGES. ALL VERIFICATION TESTING PASSED WITHIN THE PUBLISHED PERFORMANCE SPECIFICATIONS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE WASH PUMP. THE FSE REPLACED THE WASH PUMP AND RESOLVED THE AIR BUBBLES ISSUE. (B)(6). THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2014-00406.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULTS, FOR FOUR PATIENTS, INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THIS REPORT IS TWO OF TWO REFERENCING THE TWO PATIENTS ON THE EVENT DATE NOTED. THE CUSTOMER STATED THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. SUBSEQUENT TESTING OF THE PATIENTS' SAMPLES, ON THE ORIGINAL DXC 600I AND ALTERNATE ACCESS 2 SYSTEM, GENERATED LOWER RESULTS. THE CUSTOMER STATED, PER LABORATORY PROTOCOL, A SECOND SAMPLE ANALYSIS IS PERFORMED TWO HOURS FOLLOWING THE INITIAL SAMPLE. THE PATIENTS' SAMPLES WERE COLLECTED IN 13X75 MM LITHIUM PLASMA TUBES AND CENTRIFUGED AT 4,000 RPM (ROTATIONS PER MINUTE) FOR TEN MINUTES, AT AMBIENT TEMPERATURE. THE CUSTOMER STATED THE SAMPLES APPEARED NORMAL BUT ONE SAMPLE SHOWED EVIDENCE OF RED BLOOD CELLS AT THE BOTTOM AFTER RE-CENTRIFUGATION. QUALITY CONTROL (QC) IS PERFORMED DAILY. THE CUSTOMER NOTED QC AND SYSTEM CHECK WERE WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310950 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1