BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT FREE T4

    MDR report key: 24758288 · Received April 1, 2026

    Report

    Report Number
    3005094123-2026-00155
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 8, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CEC
    UDI-DI
    00380740173685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07K65-78 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7K65, WITH 510K/PMA/BLA NUMBER K173122.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. UPDATED SECTION B5 WITH ADDITIONAL PATIENT INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS GENERATED ON THE ARCHITECT I2000 ANALYZER FOR 2 PATIENTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: 11-17.7 PMOL/L): TESTING WAS COMPLETED ON (B)(6) 2026: SID (B)(6) (FEMALE, 30 YEARS-OLD): INITIAL RESULT = 33.23 PMOL/L; REPEAT RESULT = 10.74 PMOL/L SID (B)(6) (FEMALE, 31 YEARS-OLD): INITIAL RESULT = 18.01 PMOL/L; REPEAT RESULT = 13.8 PMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    ON (B)(6) 2026, THE CUSTOMER PROVIDED AN ADDITIONAL PATIENT WITH A FALSELY ELEVATED ARCHITECT FREE T4 (FT4) RESULT. THE PATIENT SAMPLE GENERATED AN INITIAL FT4 RESULT OF 30.18 PMOL/L AND THE REPEAT RESULT OF 13.59 PMOL/L. THE PATIENT IS A 33-YEAR-OLD FEMALE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78552 ARCHITECT FREE T4 RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 77458UD03 00380740173685

    Patients

    Seq Age Sex Outcome Treatment
    1