BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-TSHR

    MDR report key: 20146069 · Received September 5, 2024

    Report

    Report Number
    1823260-2024-02558
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    July 16, 2024
    Report Date
    January 14, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZO
    UDI-DI
    04015630939954
    PMA / PMN Number
    K080092
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER FACILITY NAME: (B)(6). THE SAMPLES WERE REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE PATIENT'S SAMPLE WAS TESTED. A COMPLEX INTERFERING FACTOR (AGAINST SA) AFFECTING DIFFERENT IMMUNOLOGICAL COMPONENTS OF THE ASSAYS WAS FOUND IN THE PATIENT SAMPLE DURING THE INVESTIGATION. PER PRODUCT LABELING: "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS.". THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TPO, ELECSYS ANTI-TG, ELECSYS ANTI-TSHR, AND ELECSYS TESTOSTERONE II RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH COVERS THE ALLEGED RESULTS FOR THE ELECSYS ANTI-TSHR ASSAY. PLEASE REFER TO MEDWATCH WITH A1 - PATIENT IDENTIFIER = (B)(6) FOR THE ALLEGED ELECSYS ANTI-TG ASSAY RESULTS, MEDWATCH WITH A1 - PATIENT IDENTIFIER = (B)(6) FOR THE ALLEGED ELECSYS TESTOSTERONE II ASSAY RESULTS, AND MEDWATCH WITH A1 - PATIENT IDENTIFIER = (B)(6) FOR THE ALLEGED ELECSYS ANTI-TPO ASSAY RESULTS. REFER TO THE HIGHLIGHTED SECTION OF ATTACHMENT (B)(6) FOR PATIENT RESULTS. THE SAMPLES WERE REPEATED DUE TO THE RESULTS NOT MATCHING THE CLINICAL STATUS OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2036378 ELECSYS ANTI-TSHR ANTI-TSHR IMMUNOASSAY JZO ROCHE DIAGNOSTICS ASKU 04015630939954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CORTANCYL| LEVOTHYROX| NEOMERCAZOLE