BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM RUBELLA IGG

    MDR report key: 1604785 · Received February 18, 2010

    Report

    Report Number
    1415939-2010-00255
    Event Type
    Malfunction
    Date Received
    February 18, 2010
    Report Date
    February 10, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LFX
    PMA / PMN Number
    K954045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. AN INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT SAMPLE GENERATED A FALSE POSITIVE RESULT WITH THE AXSYM RUBELLA IGG ASSAY. THE PATIENT IS KNOWN TO BE NEGATIVE FOR RUBELLA IGG AND GENERATED AN INITIAL RESULT OF 158 IU/ML. THE SAMPLE RETESTED AT 1.20 IU/ML (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 AXSYM RUBELLA IGG FOR THE MEASUREMENT OF IGG ANTIBODY TO THE RUBELLA VIRUS LFX ABBOTT LABORATORIES 80099M100

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM PLUS REFURB G LN: 7A83-85| AXSYM PLUS REFURB G LN: 7A83-85 (B)(4)