BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP CA 19-9 ASSAY

    MDR report key: 4514325 · Received February 13, 2015

    Report

    Report Number
    1219913-2015-00027
    Event Type
    Malfunction
    Date Received
    February 13, 2015
    Date of Event
    July 9, 2013
    Report Date
    January 28, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    NIG
    PMA / PMN Number
    K031393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE ELEVATED ADVIA CENTAUR XP CA 19-9 RESULT COMPARED TO ALTERNATE METHODS IS UNKNOWN. SIEMENS HAS REQUESTED THE SAMPLE FOR INVESTIGATION. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES: "NOTE: DO NOT INTERPRET SERUM LEVELS OF CA 19-9 AS ABSOLUTE EVIDENCE OF THE PRESENCE OR THE ABSENCE OF MALIGNANT DISEASE. BEFORE TREATMENT, PATIENTS WITH CONFIRMED GI CARCINOMA FREQUENTLY HAVE LEVELS OF CA 19-9 WITHIN THE RANGE OBSERVED IN HEALTHY INDIVIDUALS. ADDITIONALLY, ELEVATED LEVELS OF CA 19-9 CAN BE OBSERVED IN PATIENTS WITH NONMALIGNANT DISEASES. MEASUREMENTS OF CA 19-9 SHOULD ALWAYS BE USED IN CONJUNCTION WITH OTHER DIAGNOSTIC PROCEDURES, INCLUDING INFORMATION FROM THE PATIENT'S CLINICAL EVALUATION."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2015-00027 ON JANUARY 28, 2015 REPORTING AN ELEVATED ADVIA CENTAUR XP CA 19-9 RESULT COMPARED TO AN ALTERNATE METHOD. MARCH 2, 2015 - ADDITIONAL INFORMATION THE CUSTOMER REPORTED THAT ADDITIONAL DIAGNOSTIC PROCEDURES SUCH AS GASTROSCOPY WERE PERFORMED AS A RESULT OF THE ELEVATED RESULT. NO TUMOR WAS FOUND. SIEMENS RECEIVED THE SAMPLE FROM THE CUSTOMER AND TESTED IT ON ADVIA CENTAUR XP CA 19-9 REAGENT LOT 052361. THE SAMPLE WAS TESTED NEAT AND TREATED WITH AN HBT AND AN NSB TUBE. NEAT: 142 U/ML; HBT: 88.9 U/ML; NSB: 119 U/ML; THESE RESULTS INDICATE AN ANTIBODY INTERFERENCE IN THE SAMPLE. CORRECTED INFORMATION THE INITIAL FILING OF MDR 1219913-2015-00027 STATED THAT ADVIA CENTAUR XP CA 19-9 REAGENT LOT 052244 WAS USED FOR THE TESTING ON (B)(6) 2013, HOWEVER, IT WAS REAGENT LOT 052338 THAT WAS USED.

    Description of Event or Problem · 1

    CUSTOMER OBSERVED AN ELEVATED ADVIA CENTAUR XP CA 19-9 RESULT COMPARED TO AN ALTERNATE METHOD. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP CA 19-9 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108710 ADVIA CENTAUR XP CA 19-9 ASSAY IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN NIG SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 052360

    Patients

    Seq Age Sex Outcome Treatment
    1