BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT FREE T4

    MDR report key: 25152233 · Received May 12, 2026

    Report

    Report Number
    3005094123-2026-00217
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 12, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CEC
    UDI-DI
    00380740173661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. 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 07K65-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07K65-74, 510K K173122.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: THE CUSTOMER REFERENCE RANGE = 0.7¿1.48 NG/DL.SID (B)(6), 36 YEARS OLD FEMALE ; INITIAL RESULT = >5 NG/DL, REPEAT RESULT = 1.30 NG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341544 ARCHITECT FREE T4 RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 79415UD03 00380740173661

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female ARC I2000SR INST, 03M74-02, ISR62673