BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT FREE T4

    MDR report key: 23154065 · Received September 26, 2025

    Report

    Report Number
    3005094123-2025-00479
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    September 17, 2025
    Report Date
    December 12, 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

    COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07K65-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7K65, WITH 510K/PMA/BLA NUMBER K173122.

    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 ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 AND PROVIDED THE FOLLOWING DATA: SAMPLE ID: (B)(6) FREE T4 INITIAL TEST RESULT WAS 19.22 PMOL/L AND THE RETEST RESULT WAS 12.12. (REFERENCE RANGE: 9.09-19.01 PMOL/L). PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 AND PROVIDED THE FOLLOWING DATA: SAMPLE ID: (B)(6) FREE T4 INITIAL TEST RESULT WAS 19.22 PMOL/L AND THE RETEST RESULT WAS 12.12. (REFERENCE RANGE: 9.09-19.01 PMOL/L) PER THE CUSTOMER DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2059153 ARCHITECT FREE T4 RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 73030UD02 00380740173678

    Patients

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