BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM

    MDR report key: 2981804 · Received February 27, 2013

    Report

    Report Number
    2122870-2013-00157
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 11, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER THAT UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM GENERATED ERRATIC TROPONIN (ACCUTNI) RESULTS THAT WERE NOT REPRODUCIBLE FOR TOTAL OF 14 PATIENTS' SAMPLES DURING THE PERIOD OF (B)(6) 2012 AND (B)(6) 2013. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED TO THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE ON (B)(4) 2013. THE FSE INSPECTED THE ANALYZER AND IDENTIFIED AN ISSUE WITH THE WASH PUMP AND WASH VALVE ALLOWING AIR TO ENTER THE FLUIDICS LINES. THE FSE REPLACED THE WASH PUMP SEAL, WASH VALVE STATOR AND SEAL. THE FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK AND VERIFIED INSTRUMENT PERFORMANCE. ALL RESULTS WERE WITHIN THE SPECIFICATIONS. THE LIKELY CAUSE OF THE EVENTS WAS PREMATURE FAILURE OF COMPONENTS OF THE WASH PUMP AND WASH VALVE. THIS REPORT DOCUMENTS THE EVENT OCCURRED ON (B)(6) 2013, ON ONE PATIENT'S SAMPLE. THE RELATED EVENTS ARE DOCUMENTED IN THE BELOW LISTED MEDICAL DEVICE REPORTS: 2122870-2013-00155, 2122870-2013-00156, 2122870-2013-00158, 2122870-2013-00159, 2122870-2013-00167, 2122870-2013-00168, 2122870-2013-00169, 2122870-2013-00170, 2122870-2013-00171, 2122870-2013-00172, 2122870-2013-00173.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83835 UNICEL® DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER DXC 600I NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74