BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1243363 · Received November 26, 2008

    Report

    Report Number
    1628664-2008-00270
    Event Type
    Malfunction
    Date Received
    November 26, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER WAS ASKED TO PERFORM A TSH PRECISION RUN ON THE AXSYM. THE PRECISION RUN GENERATED AN ACCEPTABLE MEAN, STANDARD DEVIATION AND CV%. THE COMPLAINT TEXT DOES NOT DOCUMENT THE GENERATION OF ANY ERROR CODES DUE TO THIS OCCURRENCE, AND DOES NOT DOCUMENT IF A REVIEW OF THE AXSYM MESSAGE HISTORY LOG WAS PERFORMED. ON (B)(6) 2008, THE AXSYM GENERATED ZERO RESULTS FOR THE TSH POSITIVE CONTROLS. SERVICE WAS REQUESTED. THE ABBOTT FIELD SERVICE ENGINEER (FSE) FOUND SOLUTION 4 PUMP STEP LOSS ERRORS WERE BEING GENERATED DURING PIPETTING TEST. THE FSE REPLACED AND PRIMED THE SOLUTION 4 PUMP AND TIGHTENED SAMPLE TUBING TO RESOLVE THE PUMP ERROR ISSUE. THE FSE RAN A SUCCESSFUL TSH PRECISION RUN TO VERIFY THE PERFORMANCE OF THE AXSYM. THE AXSYM SYSTEM OPERATION MANUAL (LIST NO. 9A26-06) SECTION 10, TROUBLESHOOTING AND DIAGNOSTICS, OBSERVED PROBLEMS, RESULTS ERRATIC, DISCREPANT, AND/OR EXPERIENCING IMPRECISION LISTS MULTIPLE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR INCONSISTENT, DISCREPANT, AND/OR ERRATIC RESULTS. THE PROBABLE CAUSES LISTED INCLUDE INADEQUATE WASHING/FLUSHING OF THE PROBE, AND ISSUES WITH BULK SOLUTION FLUSHING. CORRECTIVE ACTIONS LISTED INCLUDE TIGHTENING ALL TUBING FITTINGS AND VALVES, AND VERIFYING THE DELIVERY OF BULK SOLUTION 4. A REVIEW OF COMPLAINTS FOR SERIAL NUMBER (B)(4) FOR THE TIME PERIOD OF (B)(6) 2008 TO (B)(6) 2009 FOUND NO ADDITIONAL INCIDENTS OF AXSYM SERIAL NUMBER (B)(4) GENERATING INCONSISTENT RESULTS SINCE THE MALFUNCTIONING SOLUTION 4 BUFFER PUMP WAS REPLACED BY THE FSE. A REVIEW OF COMPLAINT METRICS FROM (B)(6) 2007 THROUGH (B)(6) 2008 DID NOT IDENTIFY ANY ADVERSE TRENDS DUE TO THE AXSYM TSH ASSAY GENERATING INCONSISTENT RESULTS, OR ADVERSE TRENDS DUE TO MALFUNCTIONING BUFFER PUMPS. THE CURRENT RATE FOR AXSYM ERRATIC OCCURRENCES/ MILLION TESTS AND COMPLAINTS/ MILLION TESTS ARE WITHIN EXPECTED ACTION LIMITS. BASED ON THE AVAILABLE INFORMATION AND THIS INVESTIGATION, NO DEFICIENCY WAS IDENTIFIED FOR THE AXSYM ANALYZER LIST NO. 07A83-01 RELATED TO THE ISSUE UNDER INVESTIGATION. THIS IS THE FINAL REPORT.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER STATED RESULTS ARE NOT REPRODUCIBLE ON THE AXSYM 3RD GENERATION TSH ASSAY. A PATIENT SAMPLE WAS TESTED THREE TIMES YIELDING THE FOLLOWING RESULTS: 0.014, 3.83 AND 9 UIU/ML. FIELD SERVICE WAS DISPATCHED TO INSPECT AND SERVICE THE INSTRUMENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM 3RD GEN TSH LIST #7K49-20 LOT # 69106JN00| AXSYM 3RD GEN TSH LIST #7K49-20 LOT # 69106JN00