BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 4123675 · Received September 26, 2014

    Report

    Report Number
    2122870-2014-00668
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 28, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) NOTED MICROBUBBLES AT THE TOP OF THE WASH PUMP. THE FSE REPLACED THE ROTOR ON THE WASH PUMP AND CLEANED THE VALVE MOTOR. IN ADDITION, THE FSE COMPLETED A PREVENTATIVE MAINTENANCE (PM) MINOR. 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. A DEFINITIVE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED INITIAL TROPONIN I (ACCESS ACCUTNI+3) RESULTS, FOR FOUR PATIENTS, INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER STATED THE ELEVATED RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. SUBSEQUENT TESTING OF THE PATIENTS' SAMPLES, ON AN ALTERNATE UNICEL DXC 600I, GENERATED LOWER RESULTS WITHIN THE REFERENCE RANGE. THE CUSTOMER INDICATED PRECISION TEST FAILED 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
    599979 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