BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I FREE T4 REAGENT KIT

    MDR report key: 24712729 · Received March 30, 2026

    Report

    Report Number
    3005094123-2026-00144
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 18, 2026
    Report Date
    March 27, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CEC
    UDI-DI
    00380740173715
    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 FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER: 07P70-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 07P70, 510K K173122. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED FOR A 25-YEAR-OLD PREGNANT FEMALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (NON-GRAVID REFERENCE RANGE 11-17.7 PMOL/L, FIRST TRIMESTER: 11.3-17.8 PMOL/L, SECOND TRIMESTER:9.3-15.2 PMOL/L, THIRD TRIMESTER: 7.9-14.1 PMOL/L): SAMPLE ID: (B)(6) INITIAL RESULT = >64.35 PMOL/L, REPEAT RESULTS = 12.98 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568583 ALINITY I FREE T4 REAGENT KIT RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 78042UD01 00380740173715

    Patients

    Seq Age Sex Outcome Treatment
    1