BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 4061657 · Received September 4, 2014

    Report

    Report Number
    2122870-2014-00623
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Adverse Event
    Yes
    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) NOTED BUBBLES IN THE WASH PUMP. THE FSE INSPECTED THE ROTOR AND NOTED FLARED AND WORN END. THE FSE REPLACED THE ROTOR AND RESOLVED THE REPORTED ISSUE. THE FSE PERFORMED DAILY AND WEEKLY CUSTOMER MAINTENANCE AND PRIMED THE SYSTEM; NO BUBBLES WERE OBSERVED. THE FSE PERFORMED SYSTEM CHECK, CALIBRATIONS, AND QUALITY CONTROL (QC). 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. ROTOR. FURTHER ANALYSIS OF THE RETURNED ROTOR CONFIRMED WEAR ON THE ROTOR SHAFT WHERE IT INTERACTS WITH THE WASH VALVE MOTOR COUPLER. THE INVESTIGATION COULD NOT DUPLICATE THE SYSTEM CHECK FAILURES. IN CONCLUSION, THE LIKELY CAUSE OF THE INTERMITTENT RELATIVE LIGHT UNITS (RLU) ELEVATIONS AND IMPRECISION IN SYSTEM CHECK, QUALITY CONTROL (QC), CALIBRATION, AND PATIENT RESULTS IS PREMATURE WEAR ON THE WASH VALVE ROTOR WHERE IT INTERACTS WITH THE VALVE MOTOR COUPLER. A DEFINITIVE ROOT CAUSE IS UNKNOWN. (B)(6). ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2014-00621, 2122870-2014-00622.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SYSTEM CHECK, CALIBRATION, AND QUALITY CONTROL (QC) ISSUES ON MULTIPLE ASSAYS INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER LATER STATED SIX ERRONEOUS RESULTS WERE GENERATED FOR FIVE PATIENTS. THE RESULTS WERE RELEASED OUT OF THE LABORATORY. THIS REPORT IS THREE OF THREE REFERENCING THE PATIENT ON THE EVENT DATE NOTED. THE CUSTOMER STATED THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE ERRONEOUS RESULTS. IT IS UNKNOWN IF ANY ADDITIONAL TREATMENT WAS GIVEN TO THE PATIENT. AN AMENDED REPORT WAS ISSUED TO THE HOSPITAL. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME TO DATE. THE CUSTOMER WAS ADVISED TO REANALYZE ANY QUESTIONABLE PATIENT SAMPLES FOR DISCREPANCIES; NO DISCREPANT RESULTS WERE REPORTED. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ASSESSED THE INSTRUMENT AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542840 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