BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XPT PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY

    MDR report key: 7426528 · Received January 29, 2018

    Report

    Report Number
    1219913-2018-00129
    Event Type
    Malfunction
    Date Received
    January 29, 2018
    Date of Event
    January 4, 2018
    Report Date
    January 29, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOTICS, INC
    Product Code
    MTF
    UDI-DI
    00630414203003
    PMA / PMN Number
    P950021
    Removal / Correction Number
    1219913-12/30/2015-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 1219913-2018-00129 WAS FILED ON (B)(6) 2018 REPORTING AN ADVIA CENTAUR XPT PROSTATE SPECIFIC ANTIGEN (PSA) RESULT FROM A SAMPLE WHICH WAS DEPRESSED WHEN TESTED NEAT COMPARED TO THE RESULTS FROM DILUTION OF THE SAMPLE AND TO AN ALTERNATE METHOD. JUNE 12, 2018 - ADDITION INFORMATION SIEMENS RECEIVED THE SAMPLE FROM THE CUSTOMER AND TESTED THE SAMPLE NEAT AND WITH 1/2, 1/5 AND1/200 DILUTIONS USING ADVIA CENTAUR PSA LOT 285. WHEN TESTED UNDILUTED, THE SAMPLE RECOVERED 59.75 NG/ML. WHEN DILUTED 1/2 AND 1/5, THE SAMPLE RECOVERED > 100 NG/ML. WHEN DILUTED 1/200, THE SAMPLE RECOVERED 10,328 NG/ML WHEN CORRECTED FOR THE DILUTION FACTOR. THIS IS IN LINE WITH THE RESULTS THE CUSTOMER GENERATED. NO FURTHER TESTING IS REQUIRED. THE PROCEDURAL NOTES HIGH-DOSE HOOK EFFECT SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING: "PATIENT SAMPLES WITH HIGH TOTAL PSA LEVELS CAN CAUSE A PARADOXICAL DECREASE IN THE RLUS (HIGH-DOSE HOOK EFFECT). IN THIS ASSAY, PATIENT SAMPLES WITH TOTAL PSA LEVELS AS HIGH AS 10,000 NG/ML (10,000 UG/L) WILL ASSAY GREATER THAN 100 NG/ML (100 UG/L)."

    Additional Manufacturer Narrative · 1

    THE PROCEDURAL NOTES HIGH-DOSE HOOK EFFECT SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING: "PATIENT SAMPLES WITH HIGH TOTAL PSA LEVELS CAN CAUSE A PARADOXICAL DECREASE IN THE RLUS (HIGH-DOSE HOOK EFFECT). IN THIS ASSAY, PATIENT SAMPLES WITH TOTAL PSA LEVELS AS HIGH AS 10,000 NG/ML (10,000 UG/L) WILL ASSAY GREATER THAN 100 NG/ML (100 UG/L)." GIVEN THAT THE DILUTED VALUE OF THE SAMPLE IS 11, 495 NG/ML WHICH IS GREATER THAN 10,000 NG/ML STATED IN THE IFU, THE ASSAY IS PERFORMING AS INTENDED. ADDITIONALLY, SIEMENS ISSUED URGENT FIELD CORRECTIVE ACTION CC 16-05.A.OUS AND URGENT MEDICAL DEVICE CORRECTION CC 16-05.A.US IN DECEMBER 2015 INFORMING THE CUSTOMER THAT THE ADVIA CENTAUR SYSTEMS PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY KIT LOTS ENDING IN 263 AND ABOVE ARE NOT MEETING THE CURRENT HIGH-DOSE HOOK EFFECT EXPECTATION IN THE INSTRUCTIONS FOR USE (IFU). INSTRUCTIONS ON ACTIONS TO BE TAKEN ARE PROVIDED IN THE CUSTOMER COMMUNICATION. THE COMMUNICATION STATES, "BASED ON SIEMENS' INTERNAL TESTING, SAMPLES WITH TOTAL PSA CONCENTRATIONS BETWEEN 4200 NG/ML (UG/L) AND 8400 NG/ML (UG/L) DO NOT ASSAY >100 NG/ML (UG/L) BUT INSTEAD RESULT IN FALSELY DEPRESSED CONCENTRATIONS OF APPROXIMATELY 50 NG/ML (UG/L) TO 94 NG/ML (UG/L)." SIEMENS HAS REQUESTED THE SAMPLE FOR RESEARCH AND DEVELOPMENT TO USE IN THEIR STUDIES FOR THESE COMMUNICATIONS. THE INTENDED USE SECTION OF THE IFU STATES THE FOLLOWING: "THIS IN VITRO DIAGNOSTIC ASSAY IS INTENDED TO QUANTITATIVELY MEASURE PROSTATE-SPECIFIC ANTIGEN (PSA) IN HUMAN SERUM USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP 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 LIMITATION SECTION OF THE IFU 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

    CUSTOMER OBSERVED AN ADVIA CENTAUR XPT PROSTATE SPECIFIC ANTIGEN (PSA) RESULT FROM A SAMPLE WHICH WAS DEPRESSED WHEN TESTED NEAT COMPARED TO THE RESULTS FROM DILUTION OF THE SAMPLE AND TO AN ALTERNATE METHOD. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DEPRESSED ADVIA CENTAUR XPT PSA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67497 ADVIA CENTAUR XPT PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY PSA IMMUNOASSAY MTF SIEMENS HEALTHCARE DIAGNOTICS, INC N/A 42347282 00630414203003

    Patients

    Seq Age Sex Outcome Treatment
    1