BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 3822288 · Received May 20, 2014

    Report

    Report Number
    2122870-2014-00392
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 28, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED A 10-TOOTH MIXER PULLEY WITH A FLATTENED RING. THE FSE REPLACED THE MIXER PULLEY, ASPIRATE PROBES AND PERISTALTIC PUMP TUBING. THE FSE REMOVED AND CLEANED THE WASH WHEEL AND INSPECTED THE BEARINGS. THE FSE COMPLETED PASSING SYSTEM CHECK AND HIGH SENSITIVITY (HS) SYSTEM CHECK AND PERFORMED A PRECISION TEST WHICH FAILED. THE FSE REPLACED THE PIPETTOR TIP AND MAJOR COMPONENTS ON THE ANALYTICAL MODULE AND PERFORMED ALL NECESSARY ALIGNMENTS. IN ADDITION, THE FSE ADJUSTED THE ULTRASONICS AND MIXER SPEED. THE FSE PERFORMED A PASSING SYSTEM CHECK, HS SYSTEM CHECK, AND PRECISION TEST. SERVICE ACTIVITY PERFORMED MET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. RESULTS MET 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, SYSTEM HARDWARE IS THE LIKELY CAUSE OF THE EVENT AS REPAIRS AND ADJUSTMENTS RESOLVED THE REPORTED ISSUE. HOWEVER, A SPECIFIC HARDWARE COMPONENT WAS NOT IDENTIFIED AS THE SINGULAR CAUSE OF THE EVENT. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2014-00391, 2122870-2014-00392, 2122870-2014-00393, 2122870-2014-00394.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS, FOR FOUR PATIENTS, INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THIS REPORT IS TWO OF FOUR REFERENCING THE PATIENT ON THE EVENT DATE NOTED. THE ELEVATED RESULT WAS RELEASED OUT OF THE LABORATORY. THE CUSTOMER WAS NOT AWARE OF ANY IMPACT TO PATIENT CARE. SUBSEQUENT TESTING OF THE PATIENT'S SAMPLE, ON THE ORIGINAL AND ALTERNATE INSTRUMENT, PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. AN AMENDED REPORT WAS ISSUED TO THE HOSPITAL. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE PATIENTS' SAMPLES WERE COLLECTED IN VACUTAINER LITHIUM HEPARIN TUBES AND CENTRIFUGED AT 6,000 RPM (ROTATIONS PER MINUTE) FOR FIVE MINUTES, AT ROOM TEMPERATURE. NO SAMPLE INTEGRITY ISSUES WERE OBSERVED. SYSTEM CHECK, PERFORMED ON (B)(4) 2014, INCLUDING ALL PARAMETERS, WAS WITHIN SPECIFICATIONS. THE CUSTOMER NOTED LOW LEVEL PRECISION TEST FAILED PERCENT COEFFICIENT OF VARIATION (%CV). A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300642 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR