BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR AFP ASSAY

    MDR report key: 1315779 · Received February 17, 2009

    Report

    Report Number
    1219913-2009-00016
    Event Type
    Other
    Date Received
    February 17, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOK
    PMA / PMN Number
    P930036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE FROM THIS PT WAS REQUESTED FOR EVAL TO CONFIRM, WHICH ASSAY RESULT IS CORRECT. THE PT SAMPLE HAS NOT YET BEEN RECEIVED. THE CAUSE FOR THE DIFFERENCES IN PT RESULTS BETWEEN THE ADVIA CENTAUR AND THE ALTERNATE AFP METHOD IS UNK. THE INSTRUCTIONS FOR USE CLEARLY STATE THE FOLLOWING: "WARNING: THE CONCENTRATION OF AFP IN A GIVEN SPECIMEN, AS DETERMINED BY ASSAY FROM THE DIFFERENT MANUFACTURERS, CAN VARY DUE TO DIFFERENCES IN ASSAY METHODS AND REAGENT SPECIFICITY. THE RESULTS REPORTED BY THE LABORATORY TO THE PHYSICIAN MUST INCLUDE THE IDENTITY OF THE AFP ASSAY USED. VALUES OBTAINED WITH DIFFERENT AFP ASSAY METHODS CANNOT BE USED INTERCHANGEABLY. BEFORE CHANGING ASSAY METHODS, THE LABORATORY MUST DO THE FOLLOWING: FOR PRENATAL TESTING, THE LABORATORY MUST ESTABLISH A RANGE OF NORMAL VALUES FOR THE NEW ASSAY, BASED ON NORMAL SERUM AND AMNIOTIC FLUID FROM PREGNANT WOMEN WITH A CONFIRMED GESTATIONAL AGE. FOR CANCER MANAGEMENT, THE LABORATORY MUST PERFORM ADDITIONAL TESTING TO CONFIRM BASELINE VALUES FOR PTS BEING SERIALLY MONITORED. UNITED STATES FEDERAL LAW RESTRICTS THIS DEVICE TO SALE AND DISTRIBUTION BY, OR ON THE ORDER OF A PHYSICIAN, OR TO A CLINICAL LABORATORY; AND USE IS RESTRICTED TO, BY, OR ON THE ORDER OF A PHYSICIAN. USE AFP RESULTS ONLY AS PART OF THE OVERALL CLINICAL EVAL OF A PT. DO NOT USE AFP RESULTS AS THE ONLY CRITERION FOR DIAGNOSIS. (REFER TO WARNINGS SUMMARY AND EXPLANATION OF THE TEST, AND LIMITATIONS.)".

    Description of Event or Problem · 1

    A DISCORDANT ADVIA CENTAUR AFP RESULT WAS OBTAINED ON A PT SAMPLE WHEN COMPARED TO OTHER METHODS. THE PT WAS PREVIOUSLY BEING MONITORED BY ANOTHER LABORATORY USING ROCHE E170 AND THE AFP RESULTS WERE CONSISTENTLY NEGATIVE PRE-OPERATION. POST OPERATION, THE PT SAMPLE WAS TESTED ON THE ADVIA CENTAUR AND THE RESULT WAS ELEVATED. THE PT SAMPLE WAS REPEATED IN DILUTION, BOTH MANUALLY AND ON THE ADVIA CENTAUR. THE RESULTS WERE ELEVATED. THE PT WAS REDRAWN AND TESTED ON SEVERAL METHODS. THE ADVIA CENTAUR, BECKMAN, AND KRYPTOR RESULTS WERE ELEVATED. THE OTHER THREE METHODS WERE NEGATIVE. PT TREATMENT HAS BEEN DELAYED, BECAUSE OF THE CONCERN THAT PT MAY HAVE OCCULT METASTIC NON-SEMINOMA. PT WAS PLANNED TO COMMENCE ADJUVANT CARBOPLATIN CHEMOTHERAPY. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AFP RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR AFP ASSAY AFP IMMUNOASSAY LOK SIEMENS HEALTHCARE DIAGNOSTICS, INC. NA 126

    Patients

    Seq Age Sex Outcome Treatment
    1