BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDXFLX SYSTEM

    MDR report key: 2000418 · Received February 24, 2011

    Report

    Report Number
    1628664-2011-00092
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 5, 2011
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJQ
    PMA / PMN Number
    K904226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVALUATION OF THE ISSUE CONSISTED OF A REVIEW OF CUSTOMER COMPLAINTS, A VISUAL EXAMINATION OF RETURNED MATERIAL, A REVIEW OF CURRENT (B)(4) LABELING, AND A REVIEW OF THE INFORMATION PROVIDED INCLUDING THE COMPLAINT TEXT. THE COMPLAINT INFORMATION NOTES AN FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE REAGENT DISPLAY DOOR ASSEMBLY. A SERVICE HISTORY REVIEW FOUND NO ADDITIONAL COMPLAINTS HAVE BEEN INITIATED ON (B)(4) FOR SMOKE GENERATION, SINCE THE FSR REPLACED THE REAGENT DISPLAY DOOR ASSEMBLY. THE REAGENT DISPLAY DOOR ASSEMBLY BOARD WAS RETURNED TO ABBOTT BY THE FSR. FAILURE ANALYSIS VISUALLY EXAMINED THE RETURNED REAGENT DISPLAY BOARD AND NOTED SEVERAL COMPONENTS ON THE BOARD WERE BURNED. A REVIEW OF (B)(4) FIELD PERFORMANCE DATA DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ISSUE THE CUSTOMER EXPERIENCED. THE (B)(4) SYSTEM OPERATIONS MANUAL CONTAINS ADEQUATE INFORMATION ON OPERATIONAL PRECAUTIONS AND LIMITATIONS. THE MANUAL ALSO INCLUDES DIRECTIONS FOR EMERGENCY SHUTDOWN OF THE (B)(4) ANALYZER. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE OPERATOR NOTICED SMOKE COMING FROM THE (B)(4) ANALYZER REAGENT DISPLAY. THE OPERATOR TURNED OFF THE POWER AND UNPLUGGED THE (B)(4) ANALYZER. NO INJURY TO THE OPERATOR DUE TO THE SMOKE WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1