BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT FREE T4

    MDR report key: 22505467 · Received July 15, 2025

    Report

    Report Number
    3005094123-2025-00356
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    June 24, 2025
    Report Date
    September 5, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CEC
    UDI-DI
    00380740119805
    PMA / PMN Number
    K173122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT FREE T4, LIST 07K65-34, ABBOTT IRELAND DIAGNOSTICS DIVISION, LONGFORD, IRELAND TO THE ARCHITECT I2000SR PROCESSING MODULE, LIST 03M74-97, ABBOTT LABORATORIES, IRVING, TEXAS, USA. MDR NUMBER 3016438761-2025-00515 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Additional Manufacturer Narrative · 0

    SECTION A1 - PATIENT IDENTIFIER: COMPLETE SAMPLE ID IS (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT FREE T4 RESULT GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULE FOR A 37-YEAR-OLD MALE PATIENT. THE RESULT WAS INCONSISTENT WITH ANOTHER SAMPLE COLLECTED ON THE SAME DAY. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025 AT 12:02 SID: (B)(6) RESULT = 0.84 NG/DL. (B)(6) 2025 AT 13:00 SID: (B)(6) RESULT = 0.67 NG/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY DECREASED ARCHITECT FREE T4 RESULT GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULE FOR A 37-YEAR-OLD MALE PATIENT. THE RESULT WAS INCONSISTENT WITH ANOTHER SAMPLE COLLECTED ON THE SAME DAY. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025 AT 12:02 SID: (B)(6) RESULT = 0.84 NG/DL. (B)(6) 2025 AT 13:00 SID: (B)(6) RESULT = 0.67 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535243 ARCHITECT FREE T4 RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 69104UD00 00380740119805

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male ARC I2SR REFURB-SEKAT, 03M74-97, (B)(6).| ARC I2SR REFURB-SEKAT, 03M74-97, (B)(6).