BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR PSA ASSAY

    MDR report key: 5620669 · Received April 29, 2016

    Report

    Report Number
    1219913-2016-00075
    Event Type
    Malfunction
    Date Received
    April 29, 2016
    Date of Event
    April 3, 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 1219913-2016-00075 ON 04/29/2016 WITH REGARDS TO AN INCIDENT REPORTED BY THE (B)(6) MEDIA RELATED TO APPROXIMATELY 100 PATIENTS WITH ALLEGED ELEVATED ADVIA CENTAUR PSA RESULTS THAT WERE REPORTED BY A CUSTOMER OF SIEMENS. 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 (B)(6) 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 20% 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

    THERE IS NO UDI NUMBER AS THE REAGENT LOT THAT WAS USED FOR THE ADVIA CENTAUR PSA TESTING OF THE ALLEGED 100 PATIENTS HAS NOT BEEN PROVIDED. (B)(6). MEDIA INFORMATION: MEDIA ARTICLE WAS PUBLISHED APRIL 3, 2016, AND STATES FALSELY ELEVATED PSA PATIENT RESULTS BEING REPORTED SINCE DECEMBER 1, 2015. HTTP://WWW.ABC.NET.AU/NEWS/2016-04-03/CANCER-PATHOLOGY-BLUNDER-FALSE-POSITIVE-SACKING/7295132. THIS MDR IS BEING FILED BASED ON THE INFORMATION CONTAINED IN THE MEDIA ARTICLE REGARDING ALLEGED FALSE POSITIVE PSA RESULTS IN PATIENTS WITH POST RADICAL PROSTATECTOMIES. THERE IS A POTENTIAL FOR TWO ELEVATED PSA VALUES TO TRIGGER UNNECESSARY SALVAGE THERAPY WHICH CAN IMPACT RECOVERY FROM RADICAL PROSTATECTOMY OR FURTHER DAMAGE THE URINARY TRACT. SIEMENS IS UNAWARE OF THE PSA REAGENT LOTS USED OR THE REPORTED RESULTS OF THE APPROXIMATELY 100 PATIENTS AND 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

    SIEMENS HAS ACQUIRED INFORMATION WITH REGARDS TO AN INCIDENT REPORTED BY THE (B)(6) MEDIA RELATED TO APPROXIMATELY 100 PATIENTS WITH ALLEGED ELEVATED ADVIA CENTAUR PSA RESULTS THAT WERE REPORTED BY A CUSTOMER OF SIEMENS. THESE PATIENTS PREVIOUSLY HAD THEIR PROSTATE GLANDS REMOVED AND THE REPORTED PSA ASSAY RESULTS WERE CONSIDERED TO BE ELEVATED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES FOR THE ALLEGED ELEVATED ADVIA CENTAUR PSA PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277021 ADVIA CENTAUR PSA ASSAY PSA IMMUNOASSAY, MTF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1