BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR CA19-9 ASSAY

    MDR report key: 546325 · Received July 29, 2004

    Report

    Report Number
    2432235-2004-00009
    Event Type
    Other
    Date Received
    July 29, 2004
    Date of Event
    June 2, 2004
    Report Date
    July 16, 2004
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    JJE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RELATED TO FALSELY ELEVATED ADVIA CENTAUR CA 19-9 RESULTS WITH SOME PT SAMPLES ORIGINATING FROM SEVERAL CLINICAL LABORATORIES. THE INTENDED USE OF THE ADVIA CENTAUR CA19-9 ASSAY IS TO MONITOR PTS WITH KNOWN DIAGNOSIS OF GASTROINTESTINAL CANCER (WHICH MAY OR MAY NOT BE CLINICALLY IN REMISSION). IN CONSULTATION WITH BAYER'S MEDICAL AFFAIRS OFFICER THE ASSESSMENT WAS DONE THAT A FALSELY ELEVATED CA19-9 RESULT COULD LEAD TO THE CONCLUSION THAT THE PT HAD REPLAPSED AND THE RAMINFICATION MAY BE AN UNNECESSARY PT INTERVENTION, DESPITE THE ABSENCE OF RADIOGRAPHIC CORROBORATION. FURTHER INTERNAL INVESTIGATION BY BAYER CONFIRMED THE COMPLAINTS. IT WAS DETERMINED THAT A 1:2 DILUTION PROVIDED A LIMITED CORRECTION AND THIS WAS COMMUNICATED TO CUSTOMERS AS A TEMPORARY WORKAROUND VIA A CUSTOMER NOTICE. FURTHERMORE, IT WAS DETERMINED THAT THE OBSERVED FALSE ELEVATION IS ASSOCIATED WITH PARTICULAR CHARACTERISTICS OF THE ANTIBODY USED IN THE MANUFACTURE OF LOTS 75 AND 78 OF THE CA19-9 REAGENT. THE ANTIBODY USED IN THE MANUFACTURE OF THESE LOTS IS MORE SUSCEPTIBLE TO INTERFERENCE FROM HETEROPHILIC ANTIBODIES. BAYER'S INSTRUCTIONS FOR USE FOR THE ADVIA CENTAUR CA19-9 ASSAY DOES HAVE SPECIFIC DISCLAIMERS FOR HETEROPHILIC ANTIBODIES. NEW LOTS OF REAGENTS PRODUCED SO FAR DO NOT EXHIBIT THE SAME PRONOUNCED EFFECTS AS LOTS 75 AND 78. THIS EVENT IS BEING REPORTED SINCE THERE IS A POTENTIAL THAT A PT COULD UNDERGO UNNECESSARY INTERVENTION BASED ON THE FALSELY ELEVATED CA19-9 RESULTS. AT THIS TIME BAYER DOES NOT HAVE KNOWLEDGE OF ANY DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT IN THE UNITED STATES OR ANYWHERE ELSE IN THE WORLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR CA19-9 ASSAY IMMUNOCHEMISTRY TEST SYSTEM JJE BAYER HEALTHCARE, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other