BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDXFLX SYSTEM

    MDR report key: 1171507 · Received September 17, 2008

    Report

    Report Number
    1628664-2008-00219
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Report Date
    September 8, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K904226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    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). TDXFLX THEOPHYLLINE MONOCLONAL II ASSAY LIST#: 8A53. THE COMPLAINT TEXT INDICATES ERRATIC PATIENT AND CONTROL RESULTS WERE GENERATED ON TDXFLX SN# (B)(4) WHEN RUNNING THE THEOPHYLLINE MONOCLONAL II ASSAY. A PIPETTE CHECK WAS PERFORMED AND PASSED. THE CUSTOMER REPLACED THE REAGENT BUT THE ISSUE CONTINUED. FIELD SERVICE REPRESENTATIVE (FSR) WAS REQUESTED TO VERIFY INSTRUMENT PERFORMANCE. THE FSR REPLACED MULTIPLE WORN PARTS INCLUDING: THE VALVE BLOCK, PROBE, DILUENT SYRINGE, SAMPLE SYRINGE, PUMP BELTS ON THE DILUENT SYRINGE AND SAMPLE SYRINGE AND THE BOOM ASSEMBLY. A COMPLETE PREVENTATIVE MAINTENANCE (PM) WAS PERFORMED. ASSAY RESULTS WERE AS EXPECTED FOLLOWING FIELD SERVICE INTERVENTION. A REVIEW OF THE SERVICE HISTORY OF TDXFLX SN# (B)(4) INDICATES THERE WERE NO ADDITIONAL ERRATIC RESULT COMPLAINTS GENERATED FOLLOWING FIELD SERVICE REPLACEMENT OF THE DISPENSE COMPONENTS, PUMPS, AND BELTS AND PERFORMING A PM. REVIEW OF THE COMPLAINT DATABASE FOR THE TIME PERIOD OF (B)(6) 2008 - (B)(6) 2009 FOUND NO SIMILAR COMPLAINTS FOR THE CUSTOMER DESCRIBED ISSUE. THE MOST PROBABLE ROOT CAUSE FOR THE ERRATIC RESULTS WAS WORN DISPENSE COMPONENTS. REPLACEMENT OF THE DISPENSE COMPONENTS AND PERFORMING A PM, RETURNED THE INSTRUMENT TO SPECIFICATION. A DEFICIENCY OF THE TDXFLX SYSTEM WAS NOT IDENTIFIED. THE CUSTOMER'S ISSUE IS ADDRESSED IN THE TDXFLX SYSTEM OPERATION MANUAL (LN# 4A24-51) SECTION 10, TROUBLESHOOTING, OBSERVED PROBLEMS, ERRATIC TEST RESULTS, HIGH TEST RESULTS AND QC OUT OF RANGE PROVIDE MULTIPLE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR AN ERRATIC RESULT OR RESULTS NOT AS EXPECTED. ALSO, THE THEOPHYLLINE II PACKAGE INSERT ((B)(4)), DESCRIBES SUITABLE SPECIMENS, RESULTS, AND LIMITATIONS OF THE PROCEDURE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT RECENTLY THE TDXFLX THEOPHYLLINE MONOCLONAL II ASSAY HAS BEEN GENERATING ERRATIC RESULTS, MOST OF WHICH HAVE BEEN INITIALLY ELEVATED RESULTS THAT RETEST AT LOWER LEVELS. THE CUSTOMER GAVE THE EXAMPLE OF ONE PATIENT GENERATING RESULTS OF 15.59, 34.62, AND 7.79 UG/ML FROM THE SAME SAMPLE. NO SUSPECT RESULTS HAVE BEEN REPORTED FROM THE LAB. SEVERAL TROUBLESHOOTING PROCEDURES DID NOT RESOLVE THE ISSUE AND A SERVICE REQUEST WAS INITIATED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI TDXFLX THEOPHYLLINE MONOCLONAL II ASSAY LIST#:8A53