BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 3801263 · Received May 8, 2014

    Report

    Report Number
    2122870-2014-00342
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE WASH WHEEL SENSOR APPEARED TO BE CAUSING THE WHEEL TO HAVE A MINOR ERRATIC MIXING. THE FSE REPLACED THE WASH WHEEL SENSOR AND COMPLETED A SUCCESSFUL UNWASHED PORTION OF SYSTEM CHECK. RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS, AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS ATTRIBUTED TO THE WASH WHEEL SENSOR. BECKMAN COULTER CONTINUES TO TRACK AND TREND ANY INCIDENT RELATED TO THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNWASHED PORTION OF SYSTEM CHECK FAILED FOR IMPRECISION INVOLVING THE UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM. THE CUSTOMER STATED QUALITY CONTROL (QC) WAS WITHIN RANGE AND CONTINUED TO ANALYZE PATIENT SAMPLES. THE CUSTOMER WAS NOT AWARE ANY QUESTIONABLE RESULTS. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS 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
    278736 UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA 4.6.1

    Patients

    Seq Age Sex Outcome Treatment
    1