BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 2230956 · Received September 1, 2011

    Report

    Report Number
    1628664-2011-00598
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FALSE NEGATIVE RESULT (B)(4). NO CONSEQUENCES OR IMPACT TO PATIENT (B)(4). AN ABBOTT FIELD SERVICE ENGINEER (FSE) REPLACED THE AXSYM SAMPLING AND PROCESSING SYRINGES, THE BULK SOLUTION 3 PUMP VALVE, AND THE SAMPLING PROBE. THE FSE NOTED THE SAMPLING PROBE THAT WAS REPLACED ON THE AXSYM ANALYZER MAY NOT HAVE BEEN INSTALLED CORRECTLY. (THIS SAMPLING PROBE WAS INSTALLED BY THE CUSTOMER TO RESOLVE A PROBE CRASH ISSUE). THE FSE NOTED THE NEWLY INSTALLED SAMPLING PROBE NEEDED QUITE A BIT OF ADJUSTMENT DURING THE PROBE CALIBRATION PROCEDURE. THE FSE DOCUMENTED THE AXSYM ANALYZER PERFORMED A SUCCESSFUL CMV IGG PRECISION RUN, AND WAS WORKING ACCORDING TO EXPECTED SPECIFICATIONS AFTER SERVICE WAS COMPLETED. THE AXSYM SYSTEM OPERATION MANUAL CONTAINS ADEQUATE INFORMATION FOR RESOLVING DISCREPANT RESULT ISSUES. THE MANUAL LISTS MULTIPLE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR DISCREPANT RESULTS. THE PROBABLE CAUSES LISTED INCLUDE MISALIGNED, DIRTY OR DAMAGED PROBE, MALFUNCTION OF SAMPLING AND PROCESSING SYRINGES, AND BULK SOLUTION 3 DISPENSING IMPROPERLY. THE CMV IGG 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 THE ROUTINE MAINTENANCE PROCEDURES DEFINED IN THE AXSYM SYSTEM OPERATIONS MANUAL FOR OPTIMAL PERFORMANCE. THE INSERT ALSO NOTES AXSYM CMV IGG RESULTS SHOULD BE USED IN CONJUNCTION WITH PATIENT HISTORY AND OTHER CMV MARKERS FOR DIAGNOSIS. A 3 MONTH COMPLAINT REVIEW WAS PERFORMED. THE HISTORICAL DATA REVIEW OF AXSYM ERRATIC PATIENT RESULT COMPLAINTS DID NOT FIND ANY ADVERSE TRENDS OF AXSYM ERRATIC RESULT ISSUES. AN COMPLAINT SEARCH OF THE AXSYM SERVICE HISTORY WAS PERFORMED. NO ADDITIONAL SERVICE REQUEST OR COMPLAINT TICKETS WERE FOUND FOR DISCREPANT RESULT ISSUES FOR AXSYM SERIAL NO. (B)(4). A REVIEW OF THE SECOND QUARTER 2011 METRICS FOR THE AXSYM ANALYZER FOUND NO ADVERSE TRENDS WERE IDENTIFIED FOR ISSUES WITH AXSYMS GENERATING DISCREPANT RESULTS, OR FOR DISCREPANT RESULTS CAUSED BY ISSUES WITH AXSYM PROBES, AXSYM SYRINGES, OR AXSYM PUMP VALVES. 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 NEGATIVE AXSYM CMV IGG RESULT (13.9 IU/ML) ON A PATIENT WHO WAS KNOWN TO BE CMV IGG POSITIVE ON (B)(6) 2007 WITH BIOELISA TECHNIQUE. THE SPECIMEN WAS RERUN AFTER CENTRIFUGATION WITH A NEGATIVE AXSYM CVM IGG (4 IU/ML) RESULT. THE SPECIMEN WAS RUN AGAIN A FEW DAYS LATER WITH A POSITIVE AXSYM CMV IGG (79.50 IU/ML) RESULT. NO PATIENT INFORMATION WAS PROVIDED. THE FALSE NEGATIVE AXSYM CMV IGG 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 CMV-IGG, LIST 4B47-20