BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-TG

    MDR report key: 20048027 · Received August 23, 2024

    Report

    Report Number
    1823260-2024-02456
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 29, 2024
    Report Date
    September 18, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZO
    PMA / PMN Number
    K053426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE PATIENT SAMPLE DETERMINED THAT IT CONTAINS AN INTERFERING FACTOR AGAINST THE STREPTAVIDIN COMPONENT OF THE ELECSYS ANTI-TG ASSAY. 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 ISSUE.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE E801 ANALYZER IS (B)(6). THE PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TG RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS E 801 MODULE ANALYZER. RESULTS MEASURED ON THE E801 ANALYZER DID NOT COMPARE TO RESULTS MEASURED ON AN ABBOTT ANALYZER. THE E801 RESULTS WERE DEEMED INACCURATE BY THE CUSTOMER. THE PATIENT HAD NO HISTORY OF THYROID DISEASE, NO SIGNS OF HYPERTHYROIDISM, AND A NORMAL THYROID ULTRASOUND, BUT HAD HIGH THYROID HORMONE RESULTS ON THE E801 SYSTEM. THE CUSTOMER SUSPECTS THE PATIENT SAMPLE CONTAINS AN INTERFERING FACTOR AGAINST A COMPONENT OF THE ROCHE ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387514 ELECSYS ANTI-TG THYROID AUTOANTIBODY TEST SYSTEM JZO ROCHE DIAGNOSTICS 768452

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown