BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I FREE T4 REAGENT KIT

    MDR report key: 23154262 · Received September 26, 2025

    Report

    Report Number
    3005094123-2025-00480
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    August 31, 2024
    Report Date
    December 2, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CEC
    UDI-DI
    00380740121815
    PMA / PMN Number
    K173122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. ADDITIONAL INFORMATION FOR SECTION H10 RELATED REPORT NUMBERS: 3005094123-2025-00476, 3005094123-2025-00477, 3005094123-2025-00478, 3005094123-2025-00481.

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING DATA IDENTIFIED AN INCREASE IN COMPLAINTS FOR THE ARCHITECT FREE T4 ASSAY AS WELL AS AN INCREASE IN COMPLAINT ACTIVITY FOR THE COMPLAINT LOTS. HOWEVER, TESTING WAS PERFORMED UTILIZING RETAINED KITS OF THE COMPLAINT LOTS AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOTS ARE PERFORMING AS EXPECTED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY RELATED NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE ARCHITECT FREE T4 ASSAY AND COMPLAINT ISSUE. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT FREE T4 ASSAY, LOTS 8901UD00, 68517UD00, 65267UD00, 71236UD00 AND 73276UD00 WERE IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (PACKAGE INSERT REFERENCE RANGE USED BY THE CUSTOMER IS 0.70 TO 1.48 NG/DL): ON (B)(6) 2024: INITIAL RESULT = 2.45 NG/DL, REPEAT = 1.07 NG/DL. (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = >5 NG/DL, REPEAT ON (B)(6) = 0.92 NG/DL. (B)(6): INITIAL RESULT = 2.2 NG/DL, REPEAT = 1.22 NG/DL. (B)(6): INITIAL RESULT = 1.53 NG/DL, REPEAT = 1.34 NG/DL. (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.11 NG/DL. (B)(6) 2025: INITIAL RESULT = 1.64 NG/DL, REPEAT = 1.09 NG/DL. (B)(6): INITIAL RESULT = 2.17 NG/DL, REPEAT = 1.35 NG/DL. (B)(6): INITIAL RESULT = 5 NG/DL, REPEAT = 3.77 NG/DL. (B)(6) (SECOND): INITIAL RESULT = 1.94 NG/DL, REPEAT = 1.20 NG/DL. (B)(6): INITIAL RESULT = 1.50 NG/DL, REPEAT = 1.33 NG/DL. (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.36 NG/DL. (B)(6): INITIAL RESULT = 1.69 NG/DL, REPEAT = 1.43 NG/DL. (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.76 NG/DL. (B)(6): INITIAL RESULT = 1.72 NG/DL, REPEAT = 1.46 NG/DL. (B)(6): INITIAL RESULT = 1.62 NG/DL, REPEAT = 1.13 NG/DL. (B)(6): INITIAL RESULT = 1.52 NG/DL, REPEAT = 1.11 NG/DL. (B)(6): INITIAL RESULT = 1.92 NG/DL, REPEAT = 1.14 NG/DL. (B)(6): INITIAL RESULT = 1.65 NG/DL, REPEAT = 1.42 NG/DL. (B)(6) : INITIAL RESULT = 1.73 NG/DL, REPEAT = 1.27 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR MULTIPLE PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED (PACKAGE INSERT REFERENCE RANGE USED BY THE CUSTOMER IS 0.70 TO 1.48 NG/DL): (B)(6) 2024: INITIAL RESULT = 2.45 NG/DL, REPEAT = 1.07 NG/DL, (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = >5 NG/DL, REPEAT ON NOVEMBER 07 = 0.92 NG/DL, (B)(6): INITIAL RESULT = 2.2 NG/DL, REPEAT = 1.22 NG/DL, (B)(6): INITIAL RESULT = 1.53 NG/DL, REPEAT = 1.34 NG/DL, (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.11 NG/DL, (B)(6) 2025: INITIAL RESULT = 1.64 NG/DL, REPEAT = 1.09 NG/DL, (B)(6): INITIAL RESULT = 2.17 NG/DL, REPEAT = 1.35 NG/DL, (B)(6): INITIAL RESULT = 5 NG/DL, REPEAT = 3.77 NG/DL, (B)(6) :(SECOND): INITIAL RESULT = 1.94 NG/DL, REPEAT = 1.20 NG/DL, (B)(6): INITIAL RESULT = 1.50 NG/DL, REPEAT = 1.33 NG/DL, (B)(6): INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.36 NG/DL, (B)(6) : INITIAL RESULT = 1.69 NG/DL, REPEAT = 1.43 NG/DL, (B)(6) : INITIAL RESULT WAS >5 NG/DL, REPEAT = 1.76 NG/DL, (B)(6): INITIAL RESULT = 1.72 NG/DL, REPEAT = 1.46 NG/DL, (B)(6): INITIAL RESULT = 1.62 NG/DL, REPEAT = 1.13 NG/DL, (B)(6): INITIAL RESULT = 1.52 NG/DL, REPEAT = 1.11 NG/DL, (B)(6) : INITIAL RESULT = 1.92 NG/DL, REPEAT = 1.14 NG/DL, (B)(6) : INITIAL RESULT = 1.65 NG/DL, REPEAT = 1.42 NG/DL, (B)(6) : INITIAL RESULT = 1.73 NG/DL, REPEAT = 1.27 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123541 ALINITY I FREE T4 REAGENT KIT RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 65267UD00 00380740121815

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALIN I FREE T4 RGT 200T, 07P70-20, 68517UD00| ALIN I FREE T4 RGT 200T, 07P70-20, 68901UD00| ALIN I FREE T4 RGT 200T, 07P70-20, 71236UD00| ALIN I FREE T4 RGT 200T, 07P70-20, 73276UD00| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)