BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1912468 · Received December 2, 2010

    Report

    Report Number
    1628664-2010-00448
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    DHA
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ABBOTT FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITED AND FOUND THAT THE AXSYM ANALYZER HAD A BROKEN MATRIX CAROUSEL MOTOR GEAR WHEEL. THE FSE REPLACED THE MATRIX CAROUSEL AND PROCESSING CAROUSEL V-WHEELS. THE FSE ALSO FOUND THE SAMPLE PIPETTOR WAS DISPENSING ABOUT HALF THE EXPECTED VOLUME. THE FSE REPLACED THE SAMPLING PIPETTOR BUFFER DELIVERY PUMP. PRECISION RUNS WERE PERFORMED TO VERIFY THE AXSYM ANALYZER'S PERFORMANCE AFTER SERVICE WAS COMPLETED, AND ALL CONTROL RESULTS WERE WITHIN THE EXPECTED RANGES. THE FSE DOCUMENTED THAT THE LIKELY CAUSE OF THE DISCREPANT RESULT ISSUE WAS THE SAMPLING SIDE BUFFER PUMP DISPENSING HALF OF ITS EXPECTED VOLUME. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. THE AXSYM SYSTEM OPERATION MANUAL (LIST NO. 9A26-06) AND THE TOTAL B-HCG PACKAGE INSERT 34-7758/R3 BOTH CONTAIN INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. REVIEW OF COMPLAINT TRACKING AND TRENDING; FIELD SERVICE INTERVENTION. ANALYZER, CAROUSEL V-WHEEL.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE AXSYM ANALYZER IS GENERATING DISCREPANT PATIENT RESULTS. THE CUSTOMER STATES THAT ONE PATIENT SAMPLE GENERATED AN INITIAL TOTAL B-HCG ASSAY RESULT OF 355 MIU/ML. THE CUSTOMER THEN MADE A 1:10 DILUTION OF THE SAMPLE AND GENERATED A FINAL RESULT OF 730 MIU/ML. NO SUSPECT RESULTS HAVE BEEN REPORTED FROM THE LAB. A SERVICE CALL HAS BEEN INITIATED. 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 DHA ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM TOTAL B-HCG LN: 7K58-21| AXSYM TOTAL B-HCG LN: 7K58-21