BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP CA 19-9 ASSAY

    MDR report key: 5413603 · Received February 5, 2016

    Report

    Report Number
    1219913-2016-00029
    Event Type
    Malfunction
    Date Received
    February 5, 2016
    Date of Event
    February 2, 2016
    Report Date
    February 4, 2016
    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

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00029 ON FEBRUARY 5, 2016. 02/09/2016 ADDITIONAL INFORMATION: THE AGE OF THE PATIENT: (B)(6), PATIENT IDENTIFIER: (B)(6). THE CUSTOMER DID NOT PERFORM HBT (HETEROPHILLIC BLOCKING TUBE) AND NABT (NON-SPECIFIC ANTIBODY BLOCKING TUBE) TESTING. THE CUSTOMER DOES NOT HAVE ACCESS TO THESE TUBES. THE PATIENT SAMPLE CAN NOT BE SENT TO SIEMENS HEALTHCARE DIAGNOSTICS FOR FURTHER TESTING AND INVESTIGATION DUE TO CHINA'S CUSTOMS LIMITATIONS. THE DIFFERENCE IN RESULTS BETWEEN THE ADVIA CENTAUR XP CA19-9 ASSAY AND THE ALTERNATE METHOD ASSAYS WITH THIS ONE PATIENT SAMPLE IS MOST LIKELY DUE TO SOME UNKNOWN INTERFERENT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00029 ON FEBRUARY 5, 2016. SIEMENS FILED THE MDR 1219913-2016-00029 SUPPLEMENTAL REPORT 1 ON FEBRUARY 11, 2016. ON 02/15/2016 ADDITIONAL INFORMATION: THE CUSTOMER DILUTED THE PATIENT SAMPLE MANUALLY AND THE DILUTED RESULTS ARE AS FOLLOWS: MANUAL DILUTION ×5 3175.85 U/ML, MANUAL DILUTION ×10 3459.6 U/ML, MANUAL DILUTION ×25 3470 U/ML, MANUAL DILUTION ×50 3467 U/ML, MANUAL DILUTION ×100 3219 U/ML. THE DIFFERENCE IN RESULTS BETWEEN THE ADVIA CENTAUR XP CA19-9 ASSAY AND THE ALTERNATE METHOD ASSAYS WITH THIS ONE PATIENT SAMPLE IS MOST LIKELY DUE TO SOME UNKNOWN INTERFERENT. THE PATIENT SAMPLE IS NOT AVAILABLE FOR FURTHER INVESTIGATION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP CA19-9 RESULTS WITH THE ALTERNATE METHOD IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. 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."

    Description of Event or Problem · 1

    DISCORDANT HIGH ADVIA CENTAUR XP CA 19-9 RESULTS WERE OBTAINED FOR A PATIENT SAMPLE. THE INITIAL RESULT WAS HIGH. THE PATIENT SAMPLE WAS DILUTED AND REPEATED. THE RESULTS WERE HIGH. THE PATIENT SAMPLE WAS TESTED ON ANOTHER ADVIA CENTAUR XP AND THE RESULT WAS HIGH. THE PATIENT SAMPLE WAS TESTED ON TWO ALTERNATE METHODS AND THE RESULTS WERE NEGATIVE. THERE IS NO INDICATION OF A CANCER DIAGNOSIS FOR THIS 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
    70444 ADVIA CENTAUR XP CA 19-9 ASSAY IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN NIG SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 052374

    Patients

    Seq Age Sex Outcome Treatment
    1