BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDXFLX SYSTEM

    MDR report key: 2211793 · Received August 15, 2011

    Report

    Report Number
    1628664-2011-00568
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 21, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJQ
    PMA / PMN Number
    K904226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INVOLVEMENT (B)(4); SMOKING (B)(4); BURN OF DEVICE OR DEVICE COMPONENT (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER REPLACED THE REAGENT DISPLAY BOARD AND THE REAGENT DISPLAY DRIVER BOARD. THE TDX/FLX SYSTEM OPERATIONS MANUAL CONTAINS ADEQUATE INFORMATION ON OPERATIONAL PRECAUTIONS AND LIMITATIONS, AND DIRECTIONS FOR EMERGENCY SHUTDOWN OF THE TDX/FLX ANALYZER. A REVIEW OF COMPLAINTS AND QUALITY METRICS DID NOT IDENTIFY AN ADVERSE TREND RELATED TO THIS ISSUE. NO ADDITIONAL SERVICE REQUEST OR COMPLAINT TICKETS WERE FOUND FOR REAGENT DISPLAY BOARD ISSUES ON TDX/FLX SERIAL NO. (B)(4). THE SAFETY HAZARDS MEMO WAS FOUND TO CONTAIN INFORMATION NOTING ABBOTT DIAGNOSTIC EQUIPMENT AND ACCESSORIES ARE CERTIFIED TO THE APPROPRIATE SAFETY STANDARDS, AND ADEQUATE PROTECTION IS PROVIDED FOR THE OPERATOR AGAINST ELECTRICAL SHOCK OR BURN, EXCESSIVE TEMPERATURE, AND SPREAD OF FIRE FROM THE EQUIPMENT. BASED ON THE AVAILABLE INFORMATION AND THIS EVALUATION, NO DEFICIENCY WAS IDENTIFIED FOR THE TDX/FLX ANALYZER LIST NUMBER 04A24-01, OR THE REAGENT DISPLAY DOOR WITH BOARD FOR THE ISSUE UNDER EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THERE WAS A BURNING SMELL COMING FROM THE TDXFLX ANALYZER. THE CUSTOMER TURNED OFF THE POWER. THE FOLLOWING DAY, THE BURNING SMELL WAS STILL PRESENT AND SERVICE WAS REQUESTED. THE FIELD SERVICE ENGINEER STATED THE BURNING SMELL WAS DUE TO A SHORT IN THE REAGENT DISPLAY BOARD AND OBSERVED SMOKE DAMAGE. THE BASE BOARD AND CONNECTOR HAD BURNED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TDXFLX SYSTEM JJQ ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1