BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1023857 · Received April 1, 2008

    Report

    Report Number
    1628664-2008-00082
    Event Type
    Other
    Date Received
    April 1, 2008
    Date of Event
    September 10, 2007
    Report Date
    March 6, 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

    OTHER: (INVESTIGATION IS IN PROCESS). 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 ACCOUNT GENERATED A NONREACTIVE AXSYM HCV V3.0 RESULT ON A PT WHO WAS KNOWN TO BE HCV POSITIVE. IN 2007, THE PT TESTED AXSYM HCV V3.0 NONREACTIVE (0.35 S/CO). THE NONREACTIVE RESULT WAS QUESTIONED BY THE PHYSICIAN BECAUSE THE PT KNOWN TO BE HCV POSITIVE. THE SPECIMEN WAS REPEATED WITH AN AXSYM HCV V3.0 REACTIVE RESULT (67.87 S/CO). NO ERROR MESSAGES WERE PRESENT IN THE AXSYM ANALYZER MESSAGE LOG. THE ACCOUNT QUESTIONED WHY NO ERROR MESSAGE WAS GENERATED BY THE AXSYM ANALYZER AND REPLACED THE AXSYM ANALYZER WITH AN AXSYM PLUS ANALYZER. IN 2008, ABBOTT WAS INFORMED OF A USER REPORT TO AFFSAPS FROM THE ACCOUNT. THE USER REPORT STATED NO ERROR MESSAGE OCCURRED DURING PIPETTING ON THE AXSYM ANALYZER WHICH LEAD TO AN ERRONEOUS AXSYM HCV 3.0 RESULT. THE ACCOUNT STATED IN ADDITION TO AXSYM HCV 3.0, THE SPECIMEN WAS ALSO TESTED FOR HEPATITIS B AND HIV. A SAMPLE ALARM OCCURRED ON THE AXSYM ANALYZER FOR THE TESTING FOR THE SAME PT SPECIMEN. THE AXSYM TESTING AND OTHER SEROLOGIES GENERATED NEGATIVE RESULTS. THE NONREACTIVE AXSYM HCV 3.0 RESULT WAS NOT REPORTED OUTSIDE OF THE LAB. NO IMPACT TO PT MANAGEMENT WAS REPORTED. END OF REPORT.

    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 UNK AXSYM HCV V.3.0: LOT 52394LU02