BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT FREE T4

    MDR report key: 23342243 · Received October 20, 2025

    Report

    Report Number
    3005094123-2025-00521
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    October 10, 2025
    Report Date
    December 22, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CEC
    UDI-DI
    00380740173678
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ARCHITECT FREE T4 REAGENT LOT 73030UD02. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ARCHITECT FREE T4 ASSAY, HOWEVER, NO TRENDS WERE IDENTIFIED FOR THE COMPLAINT LOT. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND ISSUE. ACCURACY TESTING WAS COMPLETED WITH A RETAINED KIT OF THE COMPLAINT LOT. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET DURING COMPLETION OF THE PROTOCOL, DEMONSTRATING THAT THE LOT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ARCHITECT FREE T4 REAGENT LOT 73030UD02.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07K65-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07K65, 510K K173122.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT GENERATED ON AN ARCHITECT I2000SR ANALYZER FOR A 38-YEAR-OLD MALE PATIENT. SID (B)(6) INITIAL RESULT = 26.66 PMOL/L, REPEAT RESULTS = 13.39 PMOL/L (REFERENCE RANGE 9.09-19.04 PMOL/L). THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT GENERATED ON AN ARCHITECT I2000SR ANALYZER FOR A 38-YEAR-OLD MALE PATIENT. SID (B)(6) INITIAL RESULT = 26.66 PMOL/L, REPEAT RESULTS = 13.39 PMOL/L (REFERENCE RANGE 9.09-19.04 PMOL/L). THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2452406 ARCHITECT FREE T4 RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 73030UD02 00380740173678

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male ARC I2000SR INST, 03M74-02, (B)(6).