BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDX FPIA ANALYZER

    MDR report key: 1368565 · Received April 27, 2009

    Report

    Report Number
    1628664-2009-00165
    Event Type
    Malfunction
    Date Received
    April 27, 2009
    Report Date
    April 22, 2009
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJQ
    PMA / PMN Number
    K811263
    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 EVALUATION WAS PERFORMED IN RESPONSE TO THE CUSTOMER'S CONCERN WITH THE TDX ANALYZER 'S (B)(4) GENERATION OF AN ERRATIC GENTAMICIN PATIENT RESULT. NO PRODUCT EVALUATION WAS PERFORMED. THE EVALUATION OF THE ISSUE CONSISTED OF A REVIEW OF CUSTOMER COMPLAINTS, CURRENT TDX ANALYZER/REAGENT LABELING, AND THE INFORMATION PROVIDED IN THE COMPLAINT TEXT. THE TDX SYSTEM OPERATIONS MANUAL (LN:9520-22) PROVIDES ADEQUATE INFORMATION ON MAINTENANCE PROCEDURES FOR THE TDX ANALYZER. THE MANUAL LISTS CORRECTIVE ACTIONS WHEN ERRATIC RESULTS ARE GENERATED. THE GENTAMICIN PACKAGE INSERT (34-4583/R6) WAS REVIEWED AND WAS FOUND TO CONTAIN ADEQUATE INFORMATION ON SAMPLE COLLECTION AND PREPARATION FOR TESTING ANALYSIS, LIMITATIONS OF THE PROCEDURE, AND SPECIFIC PERFORMANCE CHARACTERISTICS. THE COMPLAINT TEXT NOTED THE TDX ANALYZER WAS FOUND TO HAVE A LOOSE CONNECTION BETWEEN THE PROBE AND THE CONNECTOR TUBING. A SERVICE HISTORY REVIEW FOUND THAT THIS TDX ANALYZER (B)(4) HAS NOT HAD ADDITIONAL ISSUES WITH ERRATIC RESULTS GENERATION SINCE THE LOOSE CONNECTOR TUBING WAS SERVICED. A 12 MONTH SEARCH FOR SIMILAR TDX COMPLAINTS FOUND NO ADDITIONAL COMPLAINTS WERE INITIATED DUE TO ISSUES WITH INCONSISTENT GENTAMICIN RESULTS. A MALFUNCTION OF THE TDX FPIA ANALYZER WAS IDENTIFIED. THE CURRENT INVESTIGATION INDICATED ERRATIC PATIENT RESULTS WERE MOST LIKELY CAUSED BY A LOOSE PROBE CONNECTOR TUBING. THE ACTUAL CAUSE OF THE ERRATIC RESULT GENERATION COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THE TDX HAS NOT GENERATED ERRATIC RESULTS SINCE THE LOOSE CONNECTOR TUBING WAS SERVICED. NO PRODUCT DEFICIENCY WAS FOUND. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT SAMPLE GENERATED AN INITIAL TDXFLX GENTAMICIN ASSAY RESULT OF 0.0 UG/ML. THE RESULT WAS REPORTED FROM THE LAB AND QUESTIONED. A NEW SAMPLE WAS SENT AND THIS NEW SAMPLE GENERATED A RESULT OF "HIGH" ON THE ANALYZER PRINTOUT (NO ACTUAL VALUE PROVIDED). THE INITIAL SAMPLE WAS RETESTED AND GENERATED A RESULT OF 4.0 UG/ML. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 TDXFLX GENTAMICIN ASSAY LN:9512-60| TDXFLX GENTAMICIN ASSAY LN:9512-60