BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT FREE T4

    MDR report key: 24968668 · Received April 23, 2026

    Report

    Report Number
    3005094123-2026-00190
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 6, 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS GENERATED ON THE ARCHITECT I2000SR ANALYZER FOR MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: 11-17.7 PMOL/L): ON (B)(6) 2026, SID (B)(6) (32-YEAR-OLD, FEMALE): INITIAL FT4 RESULT = 20.44 PMOL/L. REPEAT FT4 RESULT = 9.3 PMOL/L. 2ND REPEAT RESULT = 9.76 PMOL/L. ON (B)(6) 2026, SID (B)(6) (32-YEAR-OLD, FEMALE): INITIAL FT4 RESULT = 26.69 PMOL/L. REPEAT RESULT = 11.77 PMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96232 ARCHITECT FREE T4 RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 80039UD03 00380740173685

    Patients

    Seq Age Sex Outcome Treatment
    1