BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I FREE T4 REAGENT KIT

    MDR report key: 22937770 · Received September 2, 2025

    Report

    Report Number
    3005094123-2025-00424
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 25, 2025
    Report Date
    October 31, 2025
    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

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P70-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER K173122, WITH 510K/PMA/BLA NUMBER K173122. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, A SEARCH FOR SIMILAR COMPLAINTS, A TICKET TRENDING REVIEW, A DEVICE HISTORY RECORD REVIEW, A LABELING REVIEW, AND IN-HOUSE TESTING OF RETAINED REAGENT KIT. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 71598UD01. ADDITIONALLY, A REVIEW OF TRACKING AND TRENDING DATA FOR THE ALINITY I FREE T4 ASSAY IDENTIFIED AN INCREASE IN COMPLAINTS. HOWEVER, IN-HOUSE PERFORMANCE TESTING WAS PERFORMED UTILIZING RETAINED REAGENT KIT OF THE COMPLAINT LOT. ALL TESTING PASSED INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT NUMBER 71598UD01 AND THE COMPLAINT ISSUE. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I FREE T4 REAGENT, LOT NUMBER 71598UD01.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 FOR MULTIPLE PATIENTS THAT WERE NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 9.01-19.05 PMOL/L): SAMPLE 1, INITIAL FREE T4 RESULT= 27.40 PMOL/L; REPEAT RESULT= 14.13 PMOL/L, SAMPLE 2, INITIAL FREE T4 RESULT= 19.55 PMOL/L; REPEAT RESULT= 12.63 PMOL/L, SAMPLE 3, INITIAL FREE T4 RESULT >64.35 PMOL/L; REPEAT RESULT= 11.14 PMOL/L, SAMPLE 4, INITIAL FREE T4 RESULT= 58.83 PMOL/L; REPEAT RESULT= 17.24 PMOL/L . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 FOR MULTIPLE PATIENTS THAT WERE NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 9.01-19.05 PMOL/L): SAMPLE 1, INITIAL FREE T4 RESULT= 27.40 PMOL/L; REPEAT RESULT= 14.13 PMOL/L. SAMPLE 2, INITIAL FREE T4 RESULT= 19.55 PMOL/L; REPEAT RESULT= 12.63 PMOL/L. SAMPLE 3, INITIAL FREE T4 RESULT >64.35 PMOL/L; REPEAT RESULT= 11.14 PMOL/L. SAMPLE 4, INITIAL FREE T4 RESULT= 58.83 PMOL/L; REPEAT RESULT= 17.24 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828469 ALINITY I FREE T4 REAGENT KIT RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 71598UD01 00380740173715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6)