BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 2221212 · Received August 24, 2011

    Report

    Report Number
    1628664-2011-00586
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HIGH TEST RESULTS (B)(4); NO CONSEQUENCES OR IMPACT TO PATIENT (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS ASKED TO PERFORM THE MONTHLY TUBING DECONTAMINATION PROCEDURE, AND TO REPLACE THE SAMPLING PROBE. NO ADDITIONAL TROUBLESHOOTING WAS NEEDED. THE LABELING REVIEW FOUND THE AXSYM SYSTEM OPERATION MANUAL CONTAINS ADEQUATE INFORMATION TO RESOLVE DISCREPANT RESULT ISSUES. THE MANUAL LISTS MULTIPLE PROBABLE CAUSES AND CORRECTIVE ACTIONS TO RESOLVE DISCREPANT RESULTS. THE PROBABLE CAUSES INCLUDE MISALIGNED, DIRTY OR DAMAGED PROBE, AND TUBING DECONTAMINATION HAS NOT BEEN PERFORMED MONTHLY. THE MANUAL ALSO CONTAINS ADEQUATE PROCEDURES FOR CLEANING AND REPLACING THE SAMPLING PROBE, AND FOR PERFORMING THE MONTHLY TUBING DECONTAMINATION PROCEDURE. THE AFP PACKAGE INSERT CONTAINS ADEQUATE INFORMATION ON SPECIMEN COLLECTION AND PREPARATION, CAUTIONS AND LIMITATIONS OF THE PROCEDURE. THE PACKAGE INSERT NOTES IT IS IMPORTANT TO FOLLOW ROUTINE MAINTENANCE PROCEDURES DEFINED IN THE MANUAL FOR OPTIMAL AXSYM PERFORMANCE. THE INSERT ALSO NOTES AXSYM AFP RESULTS SHOULD BE USED IN CONJUNCTION WITH CLINICAL EVALUATION AND OTHER DIAGNOSTIC PROCEDURES. A SERVICE HISTORY REVIEW FOUND NO ADDITIONAL DISCREPANT RESULT COMPLAINTS HAVE BEEN DOCUMENTED FOR AXSYM SERIAL NO. (B)(4), SINCE THE MONTHLY TUBING DECONTAMINATION WAS PERFORMED AND THE SAMPLING PROBE WAS REPLACED. THE SERVICE HISTORY REVIEW FOUND NO TREND OF ISSUES FOR AXSYM SERIAL NO. (B)(4). A HISTORICAL DATA REVIEW FOUND NO COMPLAINTS HAVE BEEN OPENED IN (B)(4) OF 2011 FOR AXSYM ANALYZERS GENERATING DISCREPANT AFP PATIENT RESULTS. A REVIEW OF METRICS FOR THE AXSYM ANALYZER FOUND NO ADVERSE TRENDS IDENTIFIED FOR ISSUES WITH AXSYM DISCREPANT RESULTS, OR FOR DISCREPANT RESULTS CAUSED BY ISSUES WITH AXSYM PROBES. BASED ON THE AVAILABLE INFORMATION AND THIS EVALUATION, NO DEFICIENCY WAS IDENTIFIED FOR THE AXSYM ANALYZER LIST NUMBER 07A83-01, OR THE AXSYM PROBE LIST NO. 09A59-01 FOR THE ISSUE UNDER EVALUATION.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A FALSELY ELEVATED AXSYM AFP RESULT OF 95 NG/ML WHICH WAS NOT CONSISTENT WITH THE PATIENT'S CLINICAL HISTORY. THE SPECIMEN WAS FROZEN AND RERUN THE NEXT DAY WITH AN AXSYM AFP OF 1.18 NG/ML, WHICH WAS CONSISTENT WITH THE PATIENT'S CLINICAL HISTORY. NO PATIENT INFORMATION WAS PROVIDED. THE ELEVATED AXSYM AFP RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM AFP, LIST 7K52| AXSYM AFP, LIST 7K52