BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMX ANALYZER

    MDR report key: 1360289 · Received April 14, 2009

    Report

    Report Number
    1628664-2009-00155
    Event Type
    Malfunction
    Date Received
    April 14, 2009
    Date of Event
    April 13, 2009
    Report Date
    April 13, 2009
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJQ
    PMA / PMN Number
    K864319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WENT TO THE CUSTOMER SITE AND FOUND THE CABLE ON THE AIR HEATER UNIT WAS BURNED. THE FSR COULD NOT DETERMINE IF THE ANALYZER'S FAN OR HEATER HAD CAUSED THE CABLE DAMAGE, SO THE FSR REPLACED BOTH COMPONENTS. THE FSR PERFORMED A PASSING TEMPERATURE CALIBRATION, PROBE CALIBRATION AND DISPENSE CHECK TO VERIFY THE IMX ANALYZER PERFORMANCE. THE CUSTOMER WAS SATISFIED WITH THE PERFORMANCE OF THE IMX ANALYZER AFTER SERVICE WAS COMPLETED. THE IMX OPERATION MANUAL (LIST NUMBER 08376-06) WAS REVIEWED AND WAS FOUND TO CONTAIN ADEQUATE INFORMATION ON MAINTENANCE AND TROUBLESHOOTING PROCEDURES FOR ADDRESSING THE CUSTOMER'S ISSUE. A TWELVE-MONTH REVIEW OF COMPLAINTS FOR THIS ISSUE WAS PERFORMED AND ONE ADDITIONAL COMPLAINT WAS FOUND TO HAVE BEEN INITIATED DUE TO A CUSTOMER OBSERVING VISIBLE SMOKE COMING FROM AN IMX ANALYZER. THE FSR REPLACED THE AIR HEATER INSULATOR, THE IMX MOTOR DRIVER PWA, THE IMX VDE MOTOR DRIVER PWA, AND THE IMX AIR HEATER TO RESOLVE THE ISSUE. A SEARCH OF THE IMX SERVICE HISTORY FOUND NO ADDITIONAL CUSTOMER COMPLAINTS FOR THIS IMX ANALYZER ((B)(4)) HAVE BEEN INITIATED SINCE THE FSR REPLACED THE IMX AIR HEATER. NO ADVERSE TRENDS WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION AND THIS EVALUATION, NO DEFICIENCY WAS IDENTIFIED FOR THE IMX ANALYZER LIST NUMBER 08389-01, OR THE IMX AIR HEATER PART NO. 3-04521-01 RELATED TO THE ISSUE UNDER EVALUATION. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE IMX ANALYZER GENERATED A REMOTE TEMPERATURE LOW ERROR WHILE ATTEMPTING TO CALIBRATE THE TACROLIMUS ASSAY. THE CUSTOMER NOTICED A BURNING SMELL AND WHEN THE COVER OF THE INSTRUMENT WAS OPENED, SMOKE WAS OBSERVED COMING FROM THE BASE OF THE ANALYZER. THE CUSTOMER REQUESTED A SERVICE CALL. THE CUSTOMER UNPLUGGED THE ANALYZER. THERE ARE NO REPORTS OF ANY INJURIES ASSOCIATED WITH THIS ISSUE OR DAMAGE TO THE SURROUNDING ENVIRONMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMX ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJQ ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1