BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDX FPIA ANALYZER

    MDR report key: 972139 · Received January 2, 2008

    Report

    Report Number
    1628664-2007-00601
    Event Type
    Malfunction
    Date Received
    January 2, 2008
    Report Date
    December 12, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K904226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABBOTT TECHNICAL SERVICE SPECIALIST (TSS) HAD BEEN IN THE LAB THAT DAY TO ADDRESS AN ISSUE RELATED TO CALIBRATIONS NOT HOLDING. THE TSS REPLACED THE BOOM, SYRINGE DRIVE ASSEMBLY, OPTICS AND ANALOG OPTICS BOARD. THE SAMPLES WERE RUN AFTER SERVICE INTERVENTION. THE LAB IS USING REAGENT LOT NUMBER 52180Q100 WITH CALIBRATOR LOT NUMBER 53621Q100. DOCUMENTATION INDICATES THE INSTRUMENT WILL BE SWAPPED OUT FOR ANOTHER AS RESOLUTION FOR ONGOING ISSUES. THE CUSTOMER'S ISSUE IS ADDRESSED IN THE THEOPHYLLINE MONOCLONAL II REAGENT PACKAGE INSERT LN 8A53 (34-4570/R6) AND THE TDX SYSTEM OPERATIONS MANUAL (LN 9520-22/31789-122). SECTIONS ON ASSAY AND INSTRUMENT CALIBRATIONS AND QUALITY CONTROL ENSURE PROPER OPERATION OF THE ASSAY AND ANALYZER. INSTRUMENT DIAGNOSTIC CHECKS AND CALIBRATIONS ENSURE OPTIMAL ANALYZER PERFORMANCE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    AN ABBOTT FIELD SERVICE REP (FSR) WAS CALLED TO THE CUSTOMER SITE TO INVESTIGATE A COMPLAINT BY THE CUSTOMER OF CALIBRATIONS NOT HOLDING ON THE TDX FPIA ANALYZER. THE FSR REPLACED THE BOOM ASSEMBLY, SYRINGE DRIVE ASSEMBLY, OPTICS ASSEMBLY AND AN ANALOG OPTICS BOARD. THE CUSTOMER THEN RAN PT SAMPLES WITH PATIENT #2 GENERATING AN INITIAL TDX THEOPHYLLINE II ASSAY RESULT OF 176 UMOL/L. THE RESULT WAS QUESTIONED BY THE MEDICAL STAFF AS BEING HIGHER THAN EXPECTED. THE SAMPLE WAS RETESTED AT A VALUE OF 79 UMOL/L. THERE IS NO IMPACT TO PT MANAGEMENT REPORTED. AN INSTRUMENT SWAP OUT WAS DISCUSSED WITH THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR LOT#: 52180Q100| TDX THEOPHYLLINE II ASSAY LIST#: 8A53-69