BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP PSA ASSAY

    MDR report key: 5913876 · Received August 30, 2016

    Report

    Report Number
    1219913-2016-00156
    Event Type
    Malfunction
    Date Received
    August 30, 2016
    Date of Event
    December 10, 2015
    Report Date
    August 30, 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 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). 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." (B)(4).

    Description of Event or Problem · 1

    SIEMENS HAS RECEIVED INFORMATION REGARDING ADVIA CENTAUR XP PSA RESULTS OF PATIENTS IDENTIFIED BY THE CUSTOMER AS HAVING TWO PSA RESULTS GREATER THAN 0.03UG/L. THERE IS ONE PATIENT THAT UNDERWENT EXTERNAL BEAM RADIOTHERAPY TREATMENT WHICH WAS NOT CLINICALLY JUSTIFIED BASED ON THE CURRENT DEFINITION OF BIOCHEMICAL RECURRENCE DESCRIBED IN THE 2013 (B)(6) GUIDELINES (I.E. A PSA VALUE GREATER THAN OR EQUAL TO 0.2UG/L THAT IS CONFIRMED BY A SECOND MEASUREMENT OF SERUM PSA THAT IS GREATER THAN OR EQUAL TO 0.2UG/L). FOR THIS PATIENT, TREATMENT WAS INITIATED WHERE PSA LEVELS WERE WELL-BELOW 0.2UG/L. THE CUSTOMER IS UNAWARE OF OTHER CLINICAL FACTORS USED IN THE DECISION TO START RADIOTHERAPY. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES BASED ON HAVING TWO ADVIA CENTAUR XP PSA RESULTS GREATER THAN 0.03UG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566436 ADVIA CENTAUR XP PSA ASSAY PSA IMMUNOASSAY, MTF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A REF. B6

    Patients

    Seq Age Sex Outcome Treatment
    1