BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1347043 · Received March 23, 2009

    Report

    Report Number
    1628664-2009-00121
    Event Type
    Malfunction
    Date Received
    March 23, 2009
    Date of Event
    March 9, 2009
    Report Date
    March 9, 2009
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    LFZ
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AXSYM PROBE LN: 9A59-01, LOT# UNKNOWN. THE AXSYM ANALYZER MESSAGE HISTORY AND MAINTENANCE RECORDS WERE REVIEWED, AND THE CUSTOMER FOUND THAT A PROCESSING PROBE CRASH OCCURRED ON (B)(6) 2009. THE PROCESSING PROBE WAS RECALIBRATED WHEN THE PROBE CRASH OCCURRED, BUT NOT REPLACED. THE CUSTOMER REPLACED AND CALIBRATED THE PROCESSING PROBE. A SERVICE HISTORY REVIEW FOUND AXSYM PLUS SERIAL NUMBER (B)(4) HAS NOT HAD ADDITIONAL ISSUES WITH DISCREPANT RESULTS GENERATION SINCE THIS PROCESSING PROBE WAS REPLACED. A REVIEW OF THE TRACKING AND TRENDING METRICS FOR THE AXSYM ANALYZER DID NOT IDENTIFY ANY ADVERSE TRENDS DUE TO TOXO IGM ASSAY INCONSISTENT RESULTS GENERATION, OR ADVERSE TRENDS DUE TO ANY AXSYM PROBE/INSTRUMENT ISSUES. THE AXSYM SYSTEM OPERATION MANUAL (B)(4) CONTAINS ADEQUATE INFORMATION ON THE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR INCONSISTENT RESULTS. THE PROBABLE CAUSES INCLUDE INCORRECT POSITIONING OF THE SAMPLING PROBE, CRASHED OR DAMAGED PROBE. THE TOXO IGM (B)(4) PACKAGE INSERT WAS FOUND TO CONTAIN ADEQUATE INFORMATION ON SPECIMEN COLLECTION AND PREPARATION, CAUTIONS AND LIMITATIONS OF THE PROCEDURE. THE PACKAGE INSERT NOTES THAT IT IS IMPORTANT TO FOLLOW THE ROUTINE MAINTENANCE PROCEDURES DEFINED IN THE AXSYM SYSTEM OPERATIONS MANUAL FOR OPTIMAL AXSYM PERFORMANCE. THE PROBABLE CAUSE WAS NOTED TO BE THE USE OF A DAMAGED/MALFUNCTIONING PROCESSING PROBE. THE ACTUAL CAUSE OF THE SUSPECT PATIENT RESULTS COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE. BASED ON THE AVAILABLE INFORMATION AND THIS EVALUATION, NO DEFICIENCY WAS IDENTIFIED FOR THE AXSYM PROBE, LIST NO. 09A59-01/AXSYM ANALYZER, LIST NO. 7A83-82 RELATED TO THE ISSUE UNDER EVALUATION. THIS IS A 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 STATES THAT ERRATIC RESULTS ARE BEING GENERATED BY THE AXSYM PLUS ANALYZER. FOR EXAMPLE, ONE PATIENT SAMPLE GENERATED AN INITIAL AXSYM TOXO IGM ASSAY INDEX RESULT OF 0.90 (POSITIVE) THAT RETESTED AT 0.10 (NEGATIVE). NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM TOXO M ASSAY LN: 9K09-20, LOT#: 70247HN01| AXSYM TOXO M ASSAY LN: 9K09-20, LOT#: 70247HN01