BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP PSA ASSAY

    MDR report key: 5644201 · Received May 10, 2016

    Report

    Report Number
    1219913-2016-00076
    Event Type
    Malfunction
    Date Received
    May 10, 2016
    Date of Event
    April 12, 2016
    Report Date
    August 18, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MTF
    PMA / PMN Number
    P950021
    Removal / Correction Number
    1219913-07/28/2016-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00076 ON 05/10/2016 FOR FALSELY ELEVATED ADVIA CENTAUR XP PSA RESULTS ON A PATIENT. ON 07/27/2016 ADDITIONAL INFORMATION: SIEMENS ISSUED AN URGENT FIELD SAFETY NOTICE CC 16-17.A.OUS AND AN URGENT MEDICAL DEVICE CORRECTION CC 16-17.A.US ON JULY 28, 2016 EMPHASIZING TO CUSTOMERS THAT THE PROSTATE-SPECIFIC ANTIGEN (PSA) VALUES SHOULD BE INTERPRETED IN ACCORDANCE WITH CURRENT CLINICAL GUIDELINES FOR DEFINING BIOCHEMICAL RECURRENCE FOLLOWING RADICAL PROSTATECTOMY (E.G., THE 2013 AMERICAN UROLOGICAL ASSOCIATION (AUA) GUIDELINES OR THE 2015 EUROPEAN ASSOCIATION OF UROLOGY (EAU)). THESE GUIDELINES DEFINE BIOCHEMICAL RECURRENCE OF PROSTATE CANCER AS A DETECTABLE OR RISING PSA VALUE POST-RADICAL PROSTATECTOMY THAT IS GREATER THAN OR EQUAL TO 0.2 NG/ML (UG/L) WITH A SECOND CONFIRMATORY LEVEL OF GREATER THAN OR EQUAL 0.2 NG/ML (UG/L). IN A RECENT STUDY CONDUCTED BY SIEMENS, THE LIMIT OF QUANTITATION (LOQ) LEVEL FOR THE ADVIA CENTAUR/XP/XPT PSA ASSAY WAS EVALUATED, AND DETERMINED TO BE 0.04 NG/ML AT THE LEVEL OF (B)(4) WITHIN LABORATORY PRECISION. THE STUDY CONFIRMS THAT THE ASSAY IS PERFORMING AS DESIGNED AND VARIABILITY SEEN IS WITHIN PRECISION PERFORMANCE EXPECTATIONS. THE INSTRUCTION FOR USE (IFU) UNDER THE INTENDED USE SECTION STATES THE FOLLOWING: "THIS IN VITRO DIAGNOSTIC ASSAY IS INTENDED TO QUANTITATIVELY MEASURE PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM USING THE ADVIA CENTAUR®, ADVIA CENTAUR XP, AND ADVIA CENTAUR XPT SYSTEMS. THIS ASSAY IS INDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS AND OLDER. THIS ASSAY IS FURTHER INDICATED AS AN AID IN THE MANAGEMENT (MONITORING) OF PATIENTS WITH PROSTATE CANCER." THE IFU UNDER THE LIMITATION SECTION STATES THE FOLLOWING:" WARNING" "DO NOT PREDICT DISEASE RECURRENCE SOLELY ON SERIAL PSA VALUES." "DO NOT INTERPRET LEVELS OF PSA AS ABSOLUTE EVIDENCE OF THE PRESENCE OR THE ABSENCE OF MALIGNANT DISEASE. BEFORE TREATMENT, PATIENTS WITH CONFIRMED PROSTATE CARCINOMA FREQUENTLY HAVE LEVELS OF PSA WITHIN THE RANGE OBSERVED IN HEALTHY INDIVIDUALS. ELEVATED LEVELS OF PSA CAN BE OBSERVED IN PATIENTS WITH NONMALIGNANT DISEASES. MEASUREMENTS OF PSA SHOULD ALWAYS BE USED IN CONJUNCTION WITH OTHER DIAGNOSTIC PROCEDURES, INCLUDING INFORMATION FROM THE PATIENT'S CLINICAL EVALUATION." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER ACTION REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE FALSELY ELEVATED ADVIA CENTAUR XP PSA RESULTS COMPARED TO THE ALTERNATE PSA TEST METHOD RESULTS IS UNKNOWN. SIEMENS IS INVESTIGATING. THE INSTRUCTION FOR USE (IFU) UNDER THE INTENDED USE SECTION STATES THE FOLLOWING: "THIS IN VITRO DIAGNOSTIC ASSAY IS INTENDED TO QUANTITATIVELY MEASURE PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM USING THE ADVIA CENTAUR®, ADVIA CENTAUR XP, AND ADVIA CENTAUR XPT SYSTEMS. THIS ASSAY IS INDICATED FOR THE MEASUREMENT OF SERUM PSA IN CONJUNCTION WITH DIGITAL RECTAL EXAM (DRE) AS AN AID IN THE DETECTION OF PROSTATE CANCER IN MEN AGED 50 YEARS AND OLDER. THIS ASSAY IS FURTHER INDICATED AS AN AID IN THE MANAGEMENT (MONITORING) OF PATIENTS WITH PROSTATE CANCER." THE IFU UNDER THE LIMITATION SECTION STATES THE FOLLOWING: " WARNING" "DO NOT PREDICT DISEASE RECURRENCE SOLELY ON SERIAL PSA VALUES." "DO NOT INTERPRET LEVELS OF PSA AS ABSOLUTE EVIDENCE OF THE PRESENCE OR THE ABSENCE OF MALIGNANT DISEASE. BEFORE TREATMENT, PATIENTS WITH CONFIRMED PROSTATE CARCINOMA FREQUENTLY HAVE LEVELS OF PSA WITHIN THE RANGE OBSERVED IN HEALTHY INDIVIDUALS. ELEVATED LEVELS OF PSA CAN BE OBSERVED IN PATIENTS WITH NONMALIGNANT DISEASES. MEASUREMENTS OF PSA SHOULD ALWAYS BE USED IN CONJUNCTION WITH OTHER DIAGNOSTIC PROCEDURES, INCLUDING INFORMATION FROM THE PATIENT'S CLINICAL EVALUATION."

    Description of Event or Problem · 1

    FALSELY ELEVATED ADVIA CENTAUR XP PSA RESULTS WERE OBTAINED ON A PATIENT SAMPLE AND REPORTED TO THE GENERAL PRACTITIONER (GP). THE GP REFERRED THE PATIENT TO AN UROLOGIST AND A NEW (SECOND) SAMPLE WAS SENT TO THE SAME LABORATORY FOR PSA TESTING. THE PSA RESULT OF THE SECOND PATIENT SAMPLE WAS SIMILAR TO THE ORIGINAL ADVIA CENTAUR XP PSA RESULTS. THE CUSTOMER PERFORMED REPEAT TESTING ON THE NEW (SECOND) PATIENT SAMPLE WITH AN ALTERNATE PSA TEST METHOD, AND THE RESULT WAS LOWER. THE ORIGINAL PATIENT SAMPLE WAS RE-TESTED WITH THE ALTERNATE PSA TEST METHOD, AND THE RESULT WAS LOWER. AN AMENDED REPORT WAS PROVIDED TO THE GP FOR THE ORIGINALLY REPORTED PSA RESULT, AND THE ALTERNATE PSA TEST METHOD RESULT FROM THE SECOND SAMPLE WAS WHAT WAS REPORTED TO THE UROLOGIST. THE PATIENT SAMPLES WERE SENT TO A SISTER LABORATORY FOR RE-TESTING ON AN ADVIA CENTAUR SYSTEM. THE PSA RESULTS WERE SLIGHTLY LOWER THAN THE ORIGINAL ADVIA CENTAUR XP RESULTS, HOWEVER CONSIDERED ELEVATED WHEN COMPARED TO THE ALTERNATE PSA TEST METHOD RESULTS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP PSA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300092 ADVIA CENTAUR XP PSA ASSAY PSA IMMUNOASSAY, MTF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 023269

    Patients

    Seq Age Sex Outcome Treatment
    1