BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP CA 19-9 ASSAY

    MDR report key: 6038229 · Received October 18, 2016

    Report

    Report Number
    1219913-2016-00185
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 27, 2016
    Report Date
    October 18, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    NIG
    PMA / PMN Number
    K031393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP CA19-9 RESULTS IS UNKNOWN. THE CUSTOMER DID NOT RUN ANY OTHER PATIENT SAMPLES WITH LOT 052384 AND LOT 052388. THE CUSTOMER HAS ACCEPTED CA19-9 LOT 052388 FOR USE. NO RESULTS WERE QUESTIONED BY PHYSICIANS FOR LOT 052384. THE PATIENT SAMPLE IS NOT AVAILABLE FOR FURTHER TESTING AND INVESTIGATION AT THE MANUFACTURER SITE. 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."

    Description of Event or Problem · 1

    A DISCORDANT HIGH ADVIA CENTAUR XP CA 19-9 RESULT WAS OBTAINED FOR A PATIENT SAMPLE DURING LOT TO LOT CORRELATION. THE CORRELATION RUN WAS BETWEEN REAGENT LOT 052384 AND LOT 052388. THE RESULTS SHOWED GREATER THAN 30% DIFFERENCE. THE REAGENT LOT 052388 WAS RECALIBRATED AND THE PATIENT SAMPLE WAS REPEATED. THE RESULT WAS HIGHER THAN THE INITIAL RESULT FROM LOT 052384. 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
    689141 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