BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2984208 · Received February 28, 2013

    Report

    Report Number
    2122870-2013-00172
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    December 19, 2012
    Report Date
    February 1, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED LOW LEVEL QUALITY CONTROL (QC) WAS OUT OF SPECIFICATION AND ERRATIC. THE FSE DISCOVERED AN ISSUE WITH THE WASH PUMP AND WASH VALVE, ALLOWING AIR TO ENTER THE FLUIDICS LINES. THE FSE INSTALLED NEW SEALS IN THE PUMP AND REPLACED THE VALVE ROTOR AND SEALS. THE FSE COMPLETED HIGH SENSITIVITY (HS) SYSTEM CHECK AND VERIFIED TROPONIN I PRECISION WAS WITHIN SPECIFICATION. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS. VALVE ROTOR. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 2122870-2013-00171, 2122870-2013-00167, 2122870-2013-00169, 2122870-2013-00173, 2122870-2013-00172, 2122870-2013-00168, 2122870-2013-00170, 2122870-2013-00159, 2122870-2013-00155.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NON-REPRODUCIBLE AND ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION AND/OR ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT, FOR MULTIPLE PATIENTS, ON SEPARATE DAYS, INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM UTILIZED IN CONJUNCTION WITH THE ACCESS ACCUTNI ASSAY. SUBSEQUENT ANALYSES OF THE PATIENTS' SAMPLES, ON THE SAME INSTRUMENT, RECOVERED LOWER RESULTS WITHIN THE RISK STRATIFICATION AND/OR WITHIN THE NORMAL REFERENCE RANGE. THE ELEVATED RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT IMPACT. THE CUSTOMER NOTED ONE SAMPLE HAD FIBRIN CLOT AFTER RE-CENTRIFUGATION. PATIENT SAMPLES WERE COLLECTED IN BECTON DICKINSON (BD) PRIMARY TUBES, MIXED IMMEDIATELY AFTER COLLECTION, AND CENTRIFUGED AT 3,300 RPM (ROTATIONS PER MINUTE) FOR TEN MINUTES IN A SWINGING BUCKET CENTRIFUGE, AT ROOM TEMPERATURE. SYSTEM CHECK AND QUALITY CONTROL (QC) HAD BEEN WITHIN SPECIFICATIONS AND WAS WITHIN THE ACCEPTABLE RANGE AT THE TIME OF THE EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87382 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR