BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM ANTI-THYROGLOBULIN II (ATGII)

    MDR report key: 20804519 · Received November 28, 2024

    Report

    Report Number
    1219913-2024-00479
    Event Type
    Malfunction
    Date Received
    November 28, 2024
    Date of Event
    October 10, 2024
    Report Date
    December 10, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JZO
    UDI-DI
    00630414245324
    PMA / PMN Number
    EXEMPT (OUS)
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 1219913-2024-00479 WAS INITIALLY FILED ON 28-NOV-2024. ADDITIONAL INFORMATION (02-DEC-2024): SIEMENS HEALTHCARE DIAGNOSTICS HAS CONCLUDED THE INVESTIGATION OF THE EVENT. A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF DISCORDANT ANTI-THYROGLOBULIN II (ATGII) PATIENT RESULT WITH THE ATELLICA IM LOT WHEN COMPARED TO HISTORICAL RESULTS OBTAINED FOR THE PATIENT WITH THE ALTERNATE ATG METHOD. SIEMENS EVALUATED CUSTOMER DATA AND SHARED A CUSTOMER BULLETIN ENTITLED "INTRODUCING THE NEW ATELLICA IM ANTI-THYROGLOBULIN II (ATGII) ASSAY (OUS)" THAT SHOWS THE PERFORMANCE OF THE ATELLICA IM ATGII ASSAY VS. OTHER ATG COMMERCIAL ASSAYS. THE DATA SHOWED THAT THERE WAS NO 100% CLINICAL CONCORDANCE BETWEEN ATGII AND ALTERNATE ATG METHOD. BASED ON THE AVAILABLE INFORMATION, THE MEASURED CONCENTRATION OF ATG IN EACH SPECIMEN CAN VARY BETWEEN ASSAYS DUE TO DIFFERENCES IN ASSAY DESIGN AND METHODOLOGY. THERE IS NO EXPECTATION THAT THE ATELLICA IM ATGII ASSAY AND ALTERNATE TEST METHODS WILL PRODUCE SIMILAR RESULTS. A SPECIFIC CAUSE FOR THE DISCORDANT RESULT WAS UNABLE TO BE DETERMINED. A PRODUCT PROBLEM WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND NO FURTHER ACTIONS ARE REQUIRED. NOTE: IN SECTION H6, CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS WERE UPDATED.

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THE OBSERVATION OF DISCORDANT ANTI-THYROGLOBULIN II (ATGII) PATIENT RESULT WHEN COMPARED TO HISTORICAL RESULTS OBTAINED FOR THE PATIENT WITH THE ALTERNATE ATG METHOD. METHOD COMPARISON STUDY BETWEEN THE ALTERNATE ATG METHOD AND ATELLICA IM ATGII ASSAY WAS PERFORMED. AS STATED IN THE LIMITATIONS SECTION OF THE ATELLICA IM ANTI-THYROGLOBULIN II (ATGII) INSTRUCTIONS FOR USE (IFU), ¿ANTI-THYROGLOBULIN VALUES OBTAINED FROM DIFFERENT TEST METHODS WILL VARY AND CANNOT BE USED INTERCHANGEABLY.¿ THERE IS NO EXPECTATION THAT ATELLICA IM ATGII AND ALTERNATE TEST METHODS WILL PRODUCE SIMILAR RESULTS. THE CUSTOMER DOES NOT HAVE PATIENT SAMPLE AVAILABLE FOR SIEMENS INVESTIGATION PURPOSES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT ANTI-THYROGLOBULIN II (ATGII) PATIENT RESULT WITH THE ATELLICA IM LOT 034 WHEN COMPARED TO HISTORICAL RESULTS OBTAINED FOR THE PATIENT WITH THE ALTERNATE ATG METHOD. THE CUSTOMER ALLEGES THAT THIS ISSUE WAS OBSERVED UPON INSTALLATION OF THE ASSAY ON (B)(6) 2024. HOWEVER, THE CUSTOMER HAS REPORTED THIS OBSERVATION OF DISCORDANCE TO SIEMENS RETROSPECTIVELY. THE CUSTOMER CONTACTED SIEMENS ON (B)(6) 2024 AND PROVIDED REPRESENTATIVE PATIENT DATA DOCUMENTED IN SECTION B6. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS OR TREATMENT RESULTING FROM THE OBSERVED RESULT DISCORDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2612623 ATELLICA IM ANTI-THYROGLOBULIN II (ATGII) ATELLICA IM ANTI-THYROGLOBULIN II (ATGII) JZO SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 59388034 00630414245324

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown