BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1132788 · Received August 19, 2008

    Report

    Report Number
    1628664-2008-00195
    Event Type
    Malfunction
    Date Received
    August 19, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE ASSISTING THE CUSTOMER IN TROUBLESHOOTING THE ISSUE, CUSTOMER SERVICE AND SUPPORT NOTED THAT THE CUSTOMER CENTRIFUGED SAMPLES FOR 5 MINUTES INSTEAD OF THE RECOMMENDED 10 MINUTES, AND THE PROBES HAD BEEN INSTALLED FOR ABOUT ONE YEAR. THE AXSYM DID NOT GENERATE ANY ERRATIC RESULTS AFTER THE CUSTOMER CLEANED AND RECALIBRATED THE PROBES, AND BEGAN CENTRIFUGING SAMPLES FOR 10 MINUTES. THE AXSYM SYSTEM OPERATION MANUAL, TROUBLESHOOTING AND DIAGNOSTICS, OBSERVED PROBLEMS, RESULTS ERRATIC, DISCREPANT, AND/OR EXPERIENCING IMPRECISION LIST MULTIPLE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR INCONSISTENT, DISCREPANT, AND/OR ERRATIC RESULTS. SECTION 9, SERVICE AND MAINTENANCE, DAILY MAINTENANCE CONTAINS ADEQUATE INFORMATION ON PERFORMING THE TEAH PROBE CLEANING PROCEDURE. SECTION 9, SERVICE AND MAINTENANCE, COMPONENT REPLACEMENT CONTAINS ADEQUATE INFO ON THE REPLACEMENT PROCEDURES FOR THE SAMPLING AND PROCESSING PROBE. THE TSH PACKAGE INSERT WAS FOUND TO CONTAIN ADEQUATE INFORMATION ON SAMPLE COLLECTION AND PREPARATION FOR ANALYSIS, AND THE ASSAY PROCEDURE. THE INSERT NOTES THAT SAMPLES CONTAINING FIBRIN, PARTICULATE MATTER OR RED BLOOD CELLS MAY GIVE INCONSISTENT OR ERRONEOUS RESULTS, AND ALL PATIENT SAMPLES MUST BE CENTRIFUGED AT AN RCF OF AT LEAST 10,000 X G FOR 10 MINUTES. THE PACKAGE INSERT ALSO NOTES IT IS IMPORTANT TO FOLLOW THE ROUTINE MAINTENANCE PROCEDURES DEFINED IN THE AXSYM SYSTEM OPERATIONS MANUAL FOR OPTIMAL AXSYM ANALYZER PERFORMANCE, AND TEST RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER DATA AND SUSPECT RESULTS SHOULD BE CONFIRMED WITH ADDITIONAL TESTING. A SERVICE HISTORY REVIEW FOUND NO ADDITIONAL INCIDENTS OF AXSYM GENERATING ERRATIC RESULTS DOCUMENTED SINCE THE MAINTENANCE WAS PERFORMED ON THE PROBES., AND THE CUSTOMER BEGAN CENTRIFUGING PATIENT SAMPLES FOR 10 MINUTES. THE DIRTY/MISALIGNED PROBES, AND SAMPLE INTEGRITY ISSUE DUE TO IMPROPER CENTRIFUGATION/PREPARATION ARE THE MOST LIKELY CAUSE OF THE ERRATIC RESULTS. THE ACTUAL CAUSE OF THE ERRATIC RESULT GENERATION COULD NOT BE DETERMINED WITH THE AVAILABLE INFO. BASED ON THE AVAILABLE INFO AND THE INVESTIGATION, NO DEFICIENCY WAS IDENTIFIED FOR THE AXSYM ANALYZER RELATED TO THE ISSUE UNDER INVESTIGATION. THIS IS THE FINAL REPORT. END OF REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED RESULTS WERE NOT REPRODUCIBLE ON THE AXSYM ULTRASENSITIVE HTSH II ASSAY. A PATIENT GENERATED AN INITIAL TSH RESULT OF 7 UIU/ML. AFTER THE SAMPLE WAS RECENTRIFUGED, TSH VALUES OF 15 AND 10 UIU/ML WERE OBTAINED. 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI AXSYM HTSH