BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR ANTI-TG (ATG)

    MDR report key: 13167803 · Received January 5, 2022

    Report

    Report Number
    1219913-2022-00002
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    November 24, 2021
    Report Date
    February 25, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JZO
    UDI-DI
    00630414579214
    PMA / PMN Number
    K012777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE THE UNITED STATES OBSERVED ADVIA CENTAUR XP ANTI-THYROGLOBULIN (ATG) PATIENT RESULTS WHICH WERE DISCORDANT RELATIVE TO RESULTS OBTAINED USING ALTERNATE METHODS. SIEMENS IS INVESTIGATING. THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, UNDER INTERPRETATION OF RESULTS: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." MDR 1219913-2022-00001 WAS SUBMITTED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 0

    SIEMENS HEALTHCARE DIAGNOSTICS FILED MDR 1219913-2022-00002 ON 2022-01-05. ADDITIONAL INFORMATION, 2022-02-10: SIEMENS HAS CONCLUDED THE INVESTIGATION. A CUSTOMER FROM OUTSIDE THE UNITED STATES OBSERVED ADVIA CENTAUR XP ANTI-THYROGLOBULIN (ATG) PATIENT RESULTS WHICH WERE DISCORDANT RELATIVE TO RESULTS OBTAINED USING ALTERNATE METHODS. DISCORDANCE WAS IDENTIFIED WHEN COMPARING RESULTS AMONG THREE ASSAYS: ADVIA CENTAUR ATG, ADVIA CENTAUR ATGII, AND IMMULITE 2000 ATG. SIEMENS NOTES THAT PATIENT RESULTS MAY VARY AMONG THESE ASSAYS FOR A NUMBER OF REASONS, INCLUDING DIFFERENCES IN ASSAY ARCHITECTURE, STANDARDIZATION, AND DIAGNOSTIC CUTOFF, AS WELL AS THE VARIABILITY IN THE EFFECT OF ANTI-TG ANTIBODIES. [ANTIBODIES TO THYROGLOBULIN ARE FREQUENTLY PRESENT IN THYROID CANCER PATIENTS, AND CAN INTERFERE WITH MEASUREMENTS TO DIFFERING EXTENTS.]. NO PRODUCT PROBLEM WAS IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND NO FURTHER INVESTIGATION IS REQUIRED. NOTES: IN SECTION H6, THE CODES FOR TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION HAVE BEEN UPDATED ON THE BASIS OF THE INVESTIGATION RESULTS. MDR 1219913-2022-00001 WAS SUBMITTED FOR THE SAME EVENT.

    Description of Event or Problem · 0

    DISCORDANT, LOW ADVIA CENTAUR XP ANTI-THYROGLOBULIN (ATG) ASSAY RESULTS WERE OBSERVED FOR TWO PATIENT SAMPLES IN A METHOD COMPARISON. THE INITIAL RESULTS FROM THE ADVIA CENTAUR XP ANALYZER WERE REPORTED TO THE PHYSICIAN, AND WERE NOT QUESTIONED. HOWEVER, REPEAT TESTING OF THE SAMPLES BY ALTERNATE METHODS PRODUCED CLINICALLY CONTRADICTORY RESULTS; THE REPEAT RESULTS WERE OBSERVED IN THE CONTEXT OF METHOD-COMPARISON TESTING, AND WERE NOT REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ATG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513312 ADVIA CENTAUR ANTI-TG (ATG) SYSTEM, TEST, THYROID AUTOANTIBODY JZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 353 00630414579214

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown