BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TSH

    MDR report key: 23051856 · Received September 15, 2025

    Report

    Report Number
    3005094123-2025-00455
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    September 2, 2025
    Report Date
    October 22, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    JLW
    UDI-DI
    00380740014247
    PMA / PMN Number
    K983442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETE INFORMATION FROM SECTION A1. PATIENT IDENTIFIER SID (B)(6).

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, FIELD DATA REVIEW AND LABELING REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER CONFIRMS THE COMPLAINT ISSUE AND NO ADDITIONAL ISSUES WERE IDENTIFIED. REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT TSH ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 73531UD00. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY RELATED NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ARCHITECT TSH REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE MEDIAN POPULATION RESULT FOR THE COMPLAINT LOT IS WITHIN ESTABLISHED LIMITS, INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY IN THE FIELD. LABELLING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT TSH REAGENT LOT 73531UD00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TSH FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 0.350-4.940 MUI/L): (B)(6) 2025, SID (B)(6), INITIAL TSH RESULT= 0.0569 MUI/L; (B)(6) 2025, HISTORICAL RESULT= 0.0483 MUI/L; REPEAT RESULT (ROCHE)= 0.77 MUI/L (REFERENCE RANGE 0.27-4.20 MUI/L); (B)(6) 2025, HISTORICAL RESULT (ROCHE)= 0.88 MUI/L; REPEAT RESULT (SIEMENS)= 0.70 MUI/L (REFERENCE RANGE 0.55-4.78 MUI/L) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ARCHITECT TSH FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 0.350-4.940 MUI/L): ON (B)(6) 2025, SID (B)(6), INITIAL TSH RESULT= 0.0569 MUI/L; (B)(6) 2025, HISTORICAL RESULT= 0.0483 MUI/L; REPEAT RESULT (ROCHE)= 0.77 MUI/L (REFERENCE RANGE 0.27-4.20 MUI/L); (B)(6) 2025, HISTORICAL RESULT (ROCHE)= 0.88 MUI/L; REPEAT RESULT (SIEMENS)= 0.70 MUI/L (REFERENCE RANGE 0.55-4.78 MUI/L) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2489420 ARCHITECT TSH RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ABBOTT IRELAND DIAGNOSTICS DIVISION 73531UD00 00380740014247

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, (B)(6)| ARC I2000SR INST, 03M74-02, (B)(6)