BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP CA 19-9 ASSAY

    MDR report key: 3191581 · Received June 26, 2013

    Report

    Report Number
    1219913-2013-00142
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 20, 2013
    Report Date
    June 11, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    NIG
    PMA / PMN Number
    K031393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS ON SITE FOR SYSTEM INSPECTION. THE FSE PERFORMED A TOTAL SERVICE CALL AND FOUND NO SYSTEM ISSUES THAT MAY HAVE CONTRIBUTED TO THE DISCORDANT LOW DILUTION RESULT. THE CUSTOMER'S QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE LIMITS AT THE TIME OF THE EVENT. THE CUSTOMER HAD RUN A 1:200 SAMPLE DILUTION WITHOUT FIRST PERFORMING A 1:10 OR 1:100 SAMPLE DILUTION AS STATED IN THE INSTRUCTION FOR USE (IFU) AND THERE WAS NOT AN OVER DILUTION SET POINT PROGRAMMED FOR OPERATOR ALERTS. THE CAUSE FOR THE DISCORDANT LOW ADVIA CENTAUR XP CA 19-9 DILUTION RESULTS IS UNKNOWN. THE ORIGINAL SAMPLE IS NOT AVAILABLE FOR FURTHER INVESTIGATION. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE (IFU) UNDER THE PROCEDURAL DILUTION SECTION STATES THE FOLLOWING: "THE FOLLOWING INFORMATION PERTAINS TO DILUTIONS: SERUM SAMPLES WITH LEVELS OF CA 19-9 GREATER THAN 700 U/ML MUST BE DILUTED AND RETESTED TO OBTAIN ACCURATE RESULTS." "PATIENT SAMPLES CAN BE AUTOMATICALLY DILUTED BY THE SYSTEM OR PREPARED MANUALLY. " "FOR AUTOMATIC DILUTIONS, ENSURE THAT ADVIA CENTAUR CA 19-9 DILUENT IS LOADED AND SET THE SYSTEM PARAMETERS AS FOLLOWS: DILUTION POINT: < OR = TO 700 U/ML DILUTION FACTOR: 10, 100, 200." THE INSTRUCTION FOR USE (IFU) UNDER THE LIMITATION SECTION STATES THE FOLLOWING 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." "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."

    Description of Event or Problem · 1

    A FALSE LOW ADVIA CENTAUR XP CA 19-9 DILUTION RESULT WAS OBSERVED BY THE CUSTOMER AND WAS CONSIDERED DISCORDANT WHEN COMPARED AN INITIAL OVER THE ASSAY UPPER LIMIT TEST RESULT AND THE PATIENT'S PREVIOUS TEST HISTORY. THE PHYSICIAN SENT IN A NEW SAMPLE FOR REPEAT TESTING AND THE INITIAL RESULT WAS OVER THE ASSAY UPPER LIMIT. THE CUSTOMER PERFORMED A SAMPLE DILUTION AND THE RESULT WAS HIGH. ANOTHER SAMPLE WAS DRAWN AT A LATER DATE AND THE CA 19-9 RESULT WAS HIGH. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW CA19-9 DILUTION RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290357 ADVIA CENTAUR XP CA 19-9 ASSAY CA 19-9 IMMUNOASSAY NIG SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 338

    Patients

    Seq Age Sex Outcome Treatment
    1