BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP CA 19-9 ASSAY

    MDR report key: 6193441 · Received December 21, 2016

    Report

    Report Number
    1219913-2016-00255
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    November 24, 2016
    Report Date
    February 22, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    NIG
    PMA / PMN Number
    K031393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIO-RAD QUALITY CONTROLS WERE WITHIN THE NORMAL RANGE AND NO INSTRUMENT ERRORS WERE FOUND WITH THE SYSTEM DURING THE EVENT. THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP CA19-9 RESULTS WITH THE ALTERNATE METHODS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. THE IFU STATES IN THE INTERPRETATION OF RESULTS SECTION: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." THE IFU STATES IN THE LIMITATIONS SECTION: "WARNING: DO NOT USE THE ADVIA CENTAUR CA 19-9 ASSAY AS A SCREENING TEST OR FOR DIAGNOSIS. DO NOT PREDICT DISEASE RECURRENCE SOLELY ON LEVELS OF ADVIA CENTAUR CA 19-9. NORMAL LEVELS OF ADVIA CENTAUR CA 19-9 DO NOT ALWAYS PRECLUDE THE PRESENCE OF DISEASE. 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. THE CONCENTRATION OF CA 19-9 IN A GIVEN SPECIMEN DETERMINED WITH ASSAYS FROM DIFFERENT MANUFACTURERS CAN VARY BECAUSE OF DIFFERENCES IN ASSAY METHODS, CALIBRATION, AND REAGENT SPECIFICITY. CA 19-9 DETERMINED WITH DIFFERENT MANUFACTURERS' ASSAYS WILL VARY DEPENDING ON THE METHOD OF STANDARDIZATION AND ANTIBODY SPECIFICITY. THEREFORE, IT IS IMPORTANT TO USE ASSAY SPECIFIC VALUES TO EVALUATE QUALITY CONTROL RESULTS."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00255 ON DECEMBER 21, 2016. ON 02/10/2017 ADDITIONAL INFORMATION: THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP CA19-9 RESULTS IS UNKNOWN. IT IS POSSIBLE THERE IS SOME SORT OF INTERFERENT FALSELY ELEVATING THE CENTAUR CA 19-9 RESULT. BASED ON THE AVAILABLE INFORMATION, THIS IS A SAMPLE SPECIFIC ISSUE AND THE ADVIA CENTAUR XP CA 19-9 ASSAY IS PERFORMING AS INTENDED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSE HIGH ADVIA CENTAUR XP CA 19-9 RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED AND THE RESULT WAS HIGH. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE NORMAL. A CORRECTED REPORT WAS ISSUED AS THE RESULTS FROM THE ALTERNATE METHODS WERE IN AGREEMENT WITH THE CLINICAL PICTURE OF THE PATIENT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 19-9 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842663 ADVIA CENTAUR XP CA 19-9 ASSAY IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN NIG SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 052388

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR