BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2761352 · Received September 26, 2012

    Report

    Report Number
    2122870-2012-01779
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 4, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) NOTICED AIR IN THE LINE TO THE ULTRASONIC TRANSDUCER. THE FSE WAS UNABLE TO LOCATE THE SOURCE AND REPLACED THE PIPETTOR LINE AND THE ULTRASONIC TRANSDUCER. THE FSE ALSO NOTED THAT THERE WAS EXCESSIVE AIR IN THE WASH PUMP AND REPLACED THE WASH PUMP AND THE MANIFOLD O-RING. THE FSE PERFORMED HIGH SENSITIVITY SYSTEM CHECK, WHICH FAILED DUE TO FLIERS. THE FSE THEN PERFORMED PREVENTIVE MAINTENANCE. A ROUTINE SYSTEM CHECK WAS PERFORMED, WHICH PASSED WITHIN SYSTEM SPECIFICATIONS, HOWEVER, HIGH SENSITIVITY SYSTEM CHECK FAILED. THE FSE RETURNED ON (B)(4)2012 AND REPLACED THE WASH CAROUSEL LATERAL BEARINGS AND MADE NECESSARY ADJUSTMENTS TO THE ALIGNMENTS. THE FSE PERFORMED ANOTHER HIGH SENSITIVITY SYSTEM WHICH AGAIN FAILED DUE TO HIGH FLIERS. THE FSE VERIFIED THE REACTION VESSEL (RV) SHUTTLE ALIGNMENTS; NO ISSUES WERE NOTED. THE FSE NOTED AIR IN THE WASH MANIFOLD BUT COULD NOT LOCATE THE SOURCE. ANOTHER FSE RETURNED TO THE FACILITY ON (B)(4) 2012 AND DISCOVERED DURING PRIMING, ONLY THE DISPENSE PROBES OF THE WASH PUMP WOULD GENERATE FOAMY MICRO-BUBBLES. THE FSE REMOVED AND CLEANED THE MANIFOLD AND ALL ASSOCIATED COMPONENTS. THE FSE ALSO INSPECTED THE TOP AND BOTTOM O-RINGS; NO ISSUES WERE NOTED. THE FSE TIGHTENED ALL HARDWARE, INSPECTED, REMOVED AND REPLACED THE WASH BUFFER SUPPLY LINE FERRULE AND INSPECTED THE WASH AND PRECISION VALVES; NO ISSUES WERE NOTED. THE FSE THEN INITIALIZED THE INSTRUMENT, PRIMED THE DISPENSE PROBES AND MONITORED FOR ANY ISSUES; NO BUBBLES WERE OBSERVED. THE FSE PERFORMED ROUTINE SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK; NO ISSUES WERE NOTED. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. THE PATIENT SAMPLES WERE CENTRIFUGED AT 3,000 RPM (REVOLUTIONS PER MINUTE) FOR TEN MINUTES. THE CUSTOMER-SUPPLIED DATA INDICATES THE CUSTOMERS QUALITY CONTROL (QC) WAS WITHIN THE LABORATORY'S ESTABLISHED RANGES AT THE TIME OF THE EVENT. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2012-01780.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED TROPONIN I (ACCESS ACCUTNI). RESULTS, WITHIN THE RISK STRATIFICATION, FOR TWO PATIENTS, ON SEPARATE DAYS INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THIS REPORT REFERENCES PATIENT #1. SUBSEQUENT TESTING OF THE PATIENT SAMPLE PRODUCED A LOWER RESULT, WITHIN THE NORMAL REFERENCE INTERVAL. AN INITIAL ELEVATED RESULT OF 0.13 NG/ML WAS OBTAINED. THE SAMPLE WAS REANALYZED TWICE AND RECOVERED VALUES OF 0.12 NG/ML AND 0.02 NG/ML. THE RESULT OF 0.02 NG/ML WAS REPORTED OUT OF THE LABORATORY AS IT CLOSELY CORRELATED WITH AN ALTERNATE METHODOLOGY'S VALUE (UNKNOWN). THE ERRONEOUS RESULT WAS NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ASSESSED THE INSTRUMENT AT THE FACILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1