BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2912251 · Received January 11, 2013

    Report

    Report Number
    2122870-2013-00027
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 17, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE WASH VALVE MOTOR AND RESOLVED THE ISSUE. 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. QUALITY CONTROL (QC) WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES AT THE TIME OF THE EVENT. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2013-00026, 2122870-2013-00027, 2122870-2013-00028, 2122870-2013-00029.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE TROPONIN I (ACCESS ACCUTNI) RESULTS AND FAILED WASHED PORTION ON THE HIGH SENSITIVITY SYSTEM CHECK INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. UPON FURTHER INVESTIGATION, THE CUSTOMER DISCOVERED THE PRECISION WASH VALVE LEAKING FLUID, AND THE HOME SENSOR HAD BECOME CORRODED. THE CUSTOMER-SUPPLIED DATA INDICATED ERRONEOUSLY ELEVATED TROPONIN I RESULTS, ABOVE THE NORMAL REFERENCE RANGE, FOR SIXTEEN (16) PATIENTS ON SEPARATE DAYS. SUBSEQUENT ANALYSIS OF THE PATIENT SAMPLES RECOVERED LOWER RESULTS, WITHIN THE NORMAL REFERENCE RANGE. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORT OF OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THE FLUID LEAK. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THIS IS REPORT TWO OF FOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18332 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1