BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXSYM CORE-M 2.0

    MDR report key: 970834 · Received December 28, 2007

    Report

    Report Number
    1415939-2007-00272
    Event Type
    Other
    Date Received
    December 28, 2007
    Date of Event
    November 29, 2007
    Report Date
    November 30, 2007
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LOM
    PMA / PMN Number
    P060009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    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 STATED, THAT A NONREACTIVE AXSYM CORE-M 2.0 RESULT OF 0.73 INDEX VALUE WAS GENERATED ON A PT THAT TESTED REACTIVE AT 1.288 INDEX VALUE USING THE IMX CORE-M METHOD. THE SAMPLE WAS DRAWN IN 2007 AND TESTED ONE MONTH LATER. THE PT TESTED IMX CORE-M REACTIVE IN THE PREVIOUS MONTH. NO IMPACT TO PT MGMT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM CORE-M 2.0 MEIA FOR THE QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B VIRUS CORE ANT LOM ABBOTT LABORATORIES NA 53208M200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR AXSYM ANALYZER LIST 7A83-95