BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TSH

    MDR report key: 22979147 · Received September 5, 2025

    Report

    Report Number
    3005094123-2025-00431
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    August 11, 2025
    Report Date
    September 23, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    JLW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07K62-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07K62, WITH 510K NUMBER K983442. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW AND FIELD DATA REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. DEVICE HISTORY REVIEW FOR THE COMPLAINT LOT DID NOT IDENTIFY ANY ISSUES. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY AN INCREASE IN COMPLAINTS FOR THE ARCHITECT TSH REAGENT AND COMPLAINT LOT FOR THE CUSTOMER REPORTED EVENT. THE OVERALL PERFORMANCE OF THE ARCHITECT TSH REAGENT REVIEWED USING FIELD DATA FROM CUSTOMERS. THE REVIEW OF FIELD DATA FOR THE COMPLAINT LOT DETERMINED THE MEDIAN VALUES ARE WITHIN THE ESTABLISHED LIMITS AND CONCLUDED THAT THE LOT GENERATED THE EXPECTED RESULTS. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT TSH REAGENT LOT 65830UD01.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TSH RESULTS FOR A 33-YEAR-OLD FEMALE UNDERGOING A PHYSICAL EXAMINATION. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 THE INITIAL TSH RESULT WAS 8.3163 UIU/ML (REFERENCE RANGE: 0.35-4.94 UIU/ML). THE FT3 AND FT4 RESULTS WERE BOTH NORMAL. (B)(6) 2025 THE INITIAL TSH RESULT WAS 4.1327 UIU/ML; THE RESULTS OF FT3 AND FT4 ASSAYS WERE NORMAL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TSH RESULTS FOR A 33-YEAR-OLD FEMALE UNDERGOING A PHYSICAL EXAMINATION. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 THE INITIAL TSH RESULT WAS 8.3163 UIU/ML (REFERENCE RANGE: 0.35-4.94 UIU/ML). THE FT3 AND FT4 RESULTS WERE BOTH NORMAL. (B)(6) 2025 THE INITIAL TSH RESULT WAS 4.1327 UIU/ML; THE RESULTS OF FT3 AND FT4 ASSAYS WERE NORMAL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264674 ARCHITECT TSH RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ABBOTT IRELAND DIAGNOSTICS DIVISION 65830UD01

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female ARC I2000SR INST, 03M74-02, (B)(6).| ARC I2000SR INST, 03M74-02, (B)(6).