BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-TSHR

    MDR report key: 22848868 · Received August 20, 2025

    Report

    Report Number
    1823260-2025-02552
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    July 5, 2025
    Report Date
    December 10, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JZO
    UDI-DI
    07613336160305
    PMA / PMN Number
    K193313
    Removal / Correction Number
    RES 98103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS E411 RACK SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    ISSUES HAVE BEEN IDENTIFIED WITH THE ELECSYS ANTI-TSHR ASSAY, PARTICULARLY AROUND THE 1.75 IU/L MEDICAL DECISION POINT. ROCHE DIAGNOSTICS HAS ISSUED AN URGENT MEDICAL DEVICE CORRECTION FOR THIS ISSUE, ENTITLED "ELECSYS® ANTI-TSHR ASSAY ¿ DEVIATIONS ON COBAS® E 411, 402, AND 801 ANALYZERS." THIS CORRECTION HAS BEEN REPORTED TO FDA. ROCHE DIAGNOSTICS INVESTIGATED AND CONFIRMED THE CUSTOMERS' ALLEGATIONS. THE ROOT CAUSE FOR THE VARIATIONS IN THE ELECSYS ANTI-TSHR ASSAY WAS AN INSUFFICIENCY OF THE ASSAY'S ROUTINE PRODUCTION PROCESS. FOR THE PLATFORM-TO-PLATFORM DEVIATION (COBAS E 411 VS. COBAS E 402/E 801), DIFFERENCES AROSE DUE TO AN INSUFFICIENT ALIGNMENT CONCEPT BETWEEN THE PLATFORMS. THESE VARIATIONS WERE FURTHER INFLUENCED BY UPDATES TO THE ROUTINE PRODUCTION PROCESS FOR THIS ASSAY. FOR THE LOT-TO-LOT DEVIATION ON E 411, MEASURES TAKEN TO ENHANCE ROBUSTNESS LED TO ADDITIONAL SHIFTS. CUSTOMERS WERE ADVISED TO IMMEDIATELY DISCONTINUE USING AND DISCARD THE AFFECTED LOT NUMBERS: 840183 AND 874011 ON THE COBAS E402/E801 ANALYZER. 840177 ON THE COBAS E411 ANALYZER. CUSTOMERS WERE ADVISED TO SWITCH TO THE NEW UNAFFECTED LOT NUMBERS: 908953 ON THE COBAS E402/E801 ANALYZER. 906872 ON THE COBAS E411 ANALYZER. THE COBAS E601 AND E602 MODULES ARE NOT AFFECTED AND CAN BE USED WITH ALL CURRENTLY AVAILABLE LOTS AND WITH THE UPCOMING LOTS WITHOUT RESTRICTIONS.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-TSHR RESULTS FROM 31 PATIENT SAMPLES TESTED ON THE COBAS E 411 ANALYZER (RACK SYSTEM). THE REPORTER STATED THAT THE HIGH RESULTS DO NOT CORRESPOND WITH THE CLINICAL PICTURE. THE PATIENT SAMPLES WERE RERUN USING A PREVIOUS ELECSYS ANTI-TSHR REAGENT LOT AND A COMPETITOR ANALYZER (SIEMENS IMMULITE). PLEASE REFER TO THE ATTACHMENT (B)(6) FOR THE TABLE CONTAINING THE EXAMPLES OF DISCREPANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373840 ELECSYS ANTI-TSHR THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM JZO ROCHE DIAGNOSTICS 84017701 07613336160305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown