BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDXFLX SYSTEM

    MDR report key: 3748031 · Received April 14, 2014

    Report

    Report Number
    1628664-2014-00073
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJQ
    PMA / PMN Number
    K904226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FURTHER EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, SERVICE HISTORY REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE CUSTOMER OBSERVED SMOKE COMING FROM THE REAGENT DISPLAY PANEL OF THE TDXFLX, SERIAL NUMBER (B)(4), THE INSTRUMENT WAS UNPLUGGED FROM THE POWER SOURCE, AND SMOKE WAS NO LONGER VISIBLE. NO FIRE WAS SEEN, AND NO INJURIES WERE REPORTED. THE FIELD SERVICE ENGINEER (FSE) IDENTIFIED THE SOURCE OF THE SMOKE AS ORIGINATING FROM A WORN REAGENT DISPLAY PANEL BOARD (PART NUMBER 3-45036-01). THE REAGENT DISPLAY BOARD WAS REPLACED, AND THE UNIT FUNCTIONED AS INTENDED. A REVIEW OF THE SERVICE HISTORY FOR TDXFLX, SERIAL NUMBER (B)(4), WAS PERFORMED, AND THE SEARCH RETURNED NO ADDITIONAL TICKETS RELATED TO VISIBLE SMOKE COMING FROM THE TDXFLX OR ISSUES WITH THE REAGENT DISPLAY PANEL BOARD (PART NUMBER 3-45036-01). BASED UPON THE RESULTS OF THIS INVESTIGATION, NO DEFICIENCY OR MALFUNCTION OF THE REAGENT DISPLAY PANEL BOARD (PART NUMBER 3-45036-01) WAS IDENTIFIED. THE ISSUE WAS RESOLVED BY REPLACING THE REAGENT DISPLAY PANEL BOARD DUE TO NORMAL WEAR.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SMOKE WAS SEEN COMING FROM THE REAGENT DISPLAY OF THE TDX/TDXFLX ANALYZER. THE CUSTOMER UNPLUGGED THE INSTRUMENT AND THE SMOKING CEASED. THERE WERE NO INJURIES TO EMPLOYEES OR DAMAGE TO THE LAB DUE TO THE SMOKE. THERE WERE NO SPARKS OR FIRE OBSERVED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL EMPLOYEE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227674 TDXFLX SYSTEM AUTOMATED FLUORESCENT IMMUNOASSAY ANALYZER JJQ ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 DOOR, REAGENT DISPLAY WITH BD, PART # 3-45036-01| DOOR, REAGENT DISPLAY WITH BD,| PART # 3-45036-01