BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDXFLX SYSTEM

    MDR report key: 1305843 · Received February 9, 2009

    Report

    Report Number
    1628664-2009-00063
    Event Type
    Malfunction
    Date Received
    February 9, 2009
    Date of Event
    February 5, 2009
    Report Date
    February 5, 2009
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJQ
    PMA / PMN Number
    K904226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 TECHNICAL SERVICE SPECIALIST ARRIVED AT THE CUSTOMER SITE AND DETERMINED THAT THE TDXFLX ANALYZER'S AIR FAN WAS NOT RUNNING AND THE AIR HEATER FUSES HAD BLOWN. THE FAN WAS REMOVED, CLEANED, AND LUBRICATED. THE AIR HEATER WAS REPLACED. ADDITIONAL PREVENTIVE MAINTENANCE (PM) VERIFICATION PROCEDURES WERE PERFORMED INCLUDING CAROUSEL CALIBRATION, 4 POT BOOM CALIBRATION, BOOM CALIBRATION, TEMPERATURE CHECK, PHOTO CALIBRATION, PHOTO CHECK AND A PIPETTE CHECK. FOLLOWING THE TROUBLESHOOTING AND DIAGNOSTIC PROCEDURES PERFORMED, THE ANALYZER WAS WORKING PER SPECIFICATIONS. A REVIEW OF THE SERVICE HISTORY RECORDS OF (B)(4) INDICATES THERE WERE NO OTHER SMOKE COMPLAINTS SINCE THE INITIATION OF THIS PRESENT COMPLAINT WITH NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER INVESTIGATION. A REVIEW OF THE COMPLAINT DATABASE FOR THE TIME PERIOD OF (B)(4) 2008 TO (B)(4) 2009 FOUND NO SIMILAR COMPLAINTS FOR THIS CUSTOMER DESCRIBED ISSUE. THE TDXFLX SYSTEM OPERATION MANUAL (LN# 04A24-51) PROVIDES ADEQUATE INFORMATION IN REGARDS TO THIS CUSTOMER ISSUE. THE MOST PROBABLE CAUSE FOR THE ISSUE WAS THE AIR FAN NOT RUNNING WITH THE AIR HEATER TEMPERATURE FUSES BEING BLOWN. THE AIR FAN WAS FOUND TO BE DIRTY. TEMPERATURE ERRORS, MAINTENANCE AND EMERGENCY SHUTDOWN PROCEDURES ARE DOCUMENTED IN THE OPERATIONS MANUAL. A DEFICIENCY OF THE TDXFLX SYSTEM WAS NOT IDENTIFIED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE DAY BEFORE, THE TDXFLX ANALYZER GAVE A "TEMP ERROR" IN THE DISPLAY AND WAS OBSERVED TO BE OVERHEATED. THE ANALYZER WAS POWERED OFF TO COOL DOWN FOR SOME TIME AND THEM POWERED BACK ON AND NORMAL OPERATIONS RESUMED. WHEN THE CUSTOMER CAME INTO THE LAB THE FOLLOWING MORNING, SHE HEARD A VERY LOW NOISE COMING FROM THE ANALYZER AND WHEN THE FRONT COVER WAS OPENED, SMOKE WAS SEEN COMING FROM INSIDE THE ANALYZER APPEARING TO ORIGINATE FROM THE REAGENT PACK AREA. ALSO, THE CUSTOMER COULD FEEL THAT THE ANALYZER WAS HOT. THE ANALYZER HAS BEEN POWERED OFF AND UNPLUGGED. IT WAS CONFIRMED THAT NO INJURIES OCCURRED BECAUSE OF THIS ISSUE. A SERVICE CALL WAS INITIATED. THERE IS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    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