BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT FREE T4 REAGENT KIT

    MDR report key: 20038909 · Received August 22, 2024

    Report

    Report Number
    3005094123-2024-00437
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    August 2, 2024
    Report Date
    October 11, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CEC
    UDI-DI
    00380740119799
    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

    RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. AN INCREASE IN COMPLAINTS HAS BEEN OBSERVED FOR LOT 61281UD00, HOWEVER, IN-HOUSE PERFORMANCE TESTING WAS COMPLETED WHICH INDICATES THE PRODUCT IS PERFORMING AS EXPECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS RELATED TO THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR ARCHITECT FREE T4 REAGENT LOT 61281UD00.

    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 ARCHITECT FREE T4 FOR ONE PATIENT WITH APLASTIC ANEMIA AND HEART FAILURE. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE OF 0.70 NG/DL TO 1.48 NG/DL): (B)(6) 2024, SID (B)(6), INITIAL RESULT (ANALYZER (B)(6)) >5.00 NG/DL; REPEAT RESULTS (ANALYZER (B)(6)) = 2.12 NG/DL AND 1.98 NG/DL; REPEAT RESULT (ANALYZER (B)(6)) >5.00 NG/DL; REPEAT RESULT AFTER ULTRACENTRIFUGATION (ANALYZER (B)(6)) = 1.43 NG/DL; REPEAT RESULT AFTER ULTRACENTRIFUGATION (ANALYZER (B)(6)) = 2.69 NG/DL. ADDITIONAL RESULTS WERE PROVIDED: INITIAL FT3 RESULT= 1.95 PG/ML; REPEAT RESULT= 1.90 PG/ML. INITIAL TSH RESULT= 3.75 UIU/ML; REPEAT RESULT= 3.31 UIU/ML. UPDATE: THE PATIENT HAD ANOTHER BLOOD SAMPLE DRAWN AND ADDITIONAL PATIENT RESULTS WERE ADDED ON (B)(6) 2024: (B)(6) 2024, FT4 (ANALYZER (B)(6)) = 1.03 NG/DL. (B)(6) 2024, FT4 (ANALYZER (B)(6)) = 1.16 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 FOR ONE PATIENT WITH APLASTIC ANEMIA AND HEART FAILURE. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE OF 0.70 NG/DL TO 1.48 NG/DL): ON (B)(6) 2024, SID (B)(6), INITIAL RESULT (ANALYZER (B)(6)) >5.00 NG/DL; REPEAT RESULTS (ANALYZER (B)(6))= 2.12 NG/DL AND 1.98 NG/DL; REPEAT RESULT (ANALYZER (B)(6)) >5.00 NG/DL; REPEAT RESULT AFTER ULTRACENTRIFUGATION (ANALYZER (B)(6))= 1.43 NG/DL; REPEAT RESULT AFTER ULTRACENTRIFUGATION (ANALYZER (B)(6))= 2.69 NG/DL. ADDITIONAL RESULTS WERE PROVIDED: INITIAL FT3 RESULT= 1.95 PG/ML; REPEAT RESULT= 1.90 PG/ML. INITIAL TSH RESULT= 3.75 UIU/ML; REPEAT RESULT= 3.31 UIU/ML. UPDATE: THE PATIENT HAD ANOTHER BLOOD SAMPLE DRAWN AND ADDITIONAL PATIENT RESULTS WERE ADDED ON (B)(6) 2024: ON (B)(6) 2024, FT4 (ANALYZER (B)(6))= 1.03 NG/DL. ON (B)(6) 2024, FT4 (ANALYZER (B)(6) )= 1.16 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941389 ARCHITECT FREE T4 REAGENT KIT RADIOIMMUNOASSAY, FREE THYROXINE CEC ABBOTT IRELAND DIAGNOSTICS DIVISION 61281UD00 00380740119799

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2K PROC MOD, 03M74-01, (B)(6) | ARC I2K PROC MOD, 03M74-01, (B)(6) | ARC I2K PROC MOD, 03M74-01, (B)(6)