BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDXFLX SYSTEM

    MDR report key: 2411226 · Received January 11, 2012

    Report

    Report Number
    1628664-2012-00009
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    December 16, 2011
    Report Date
    December 16, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJQ
    PMA / PMN Number
    K904226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE ABBOTT FIELD SERVICE REPRESENTATIVE REPLACED THE TDXFLX REAGENT CAROUSEL MOTOR AND THE FLX REAGENT DISPLAY DRIVER #6 BOARD. A PRODUCT LABELING REVIEW FOUND THE TDXFLX SYSTEM OPERATIONS MANUAL AND THE TDXFLX ANALYZER SERVICE MANUAL CONTAIN ADEQUATE INFORMATION FOR THE DESCRIBED ISSUE. THE REVIEW ALSO FOUND THE SAFETY HAZARDS MEMO CONTAINS ADEQUATE 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. A REVIEW OF QUALITY METRICS DID NOT IDENTIFY ANY ADVERSE OR NON-STATISTICAL TREND OF A TDXFLX, REAGENT CAROUSEL MOTOR, OR FLX REAGENT DISPLAY DRIVER #6 BOARD ISSUE. NO DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE AREA OVER THE TDXFLX REAGENT CAROUSEL GEAR WAS VERY HOT TO THE TOUCH. THE CUSTOMER DID NOT BELIEVE THE GEAR WAS HOT ENOUGH TO BURN OR CAUSE INJURY. THE CUSTOMER REQUESTED SERVICE. NO SMOKE OR FIRE WAS OBSERVED AND NO INJURY OCCURRED.

    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