ARCHITECT FREE T4

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR ONE (B)(6) YEAR OLD MALE PATIENT WITH PRE-EXISTING HEART FAILURE IN STABLE CONDITION. THE PATIENT¿S FT4 WAS LOWER WITH ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025 ARCHITECT RESULTS = >5.00 AND >5.00 NG/DL USING REAGENT LOT 73547UD00. (B)(6) 2025 ARCHITECT RESULT = >5.00 NG/DL USING REAGENT LOT 76216UD00. (B)(6) 2025 ARCHITECT RESULT = >5.00 NG/DL USING REAGENT LOT 76216UD00. (B)(6) 2025 ARCHITECT RESULT = >5.00 NG/DL USING REAGENT LOT 76216UD00. TREATMENT: POTASSIUM IODIDE PRESCRIPTION STARTING (B)(6) 2025. NORMAL REFERENCE RANGE = FT4 0.70-1.48NG/DL. (B)(6) 2025 RECEPTOR ANTIBODY, THYROGLOBULIN ANTIBODY, TPO ANTIBODY: NORMAL. RESULTS OF OUTSOURCED TESTING (1STEP METHOD) FT4: 1.25 NG/DL. ADDITIONAL DATA PROVIDED 02DEC2025: REFERENCE LAB RESULTS: REPRODUCIBILITY TEST: FT4 (NG/DL) 1.02. ADDITION OF HETEROPHILE ANTIBODY BLOCKERS FOR FT4 DID NOT RESULT IN A SIGNIFICANT DECREASE IN THE MEASURED VALUES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR ONE (B)(6) YEAR OLD MALE PATIENT WITH PRE-EXISTING HEART FAILURE IN STABLE CONDITION. THE PATIENT¿S FT4 WAS LOWER WITH ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025 ARCHITECT RESULTS = >5.00 AND >5.00 NG/DL USING REAGENT LOT 73547UD00, (B)(6) 2025 ARCHITECT RESULT = >5.00 NG/DL USING REAGENT LOT 76216UD00, (B)(6) 2025 ARCHITECT RESULT = >5.00 NG/DL USING REAGENT LOT 76216UD00, (B)(6) 2025 ARCHITECT RESULT = >5.00 NG/DL USING REAGENT LOT 76216UD00. TREATMENT: POTASSIUM IODIDE PRESCRIPTION STARTING (B)(6) 2025. NORMAL REFERENCE RANGE = FT4 0.70-1.48NG/DL. ON (B)(6) 2025 RECEPTOR ANTIBODY, THYROGLOBULIN ANTIBODY, TPO ANTIBODY: NORMAL. RESULTS OF OUTSOURCED TESTING (1STEP METHOD) FT4: 1.25 NG/DL. ADDITIONAL DATA PROVIDED (B)(6) 2025: REFERENCE LAB RESULTS: REPRODUCIBILITY TEST: FT4 (NG/DL) 1.02. ADDITION OF HETEROPHILE ANTIBODY BLOCKERS FOR FT4 DID NOT RESULT IN A SIGNIFICANT DECREASE IN THE MEASURED VALUES. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, A TICKET TRENDING REVIEW, A DEVICE HISTORY RECORD REVIEW, AND A LABELING REVIEW. IN ADDITION, IN-HOUSE TESTING OF RETAINED REAGENT KIT WAS ALSO COMPLETED. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING DATA FOR THE ARCHITECT FREE T4 ASSAY (LIST NUMBER 07K65) DID IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. HOWEVER, AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 73547UD00 WAS NOT IDENTIFIED. ADDITIONALLY, IN-HOUSE PERFORMANCE TESTING WAS PERFORMED UTILIZING RETAINED REAGENT KIT OF LOT 73547UD00. 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 73547UD00 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 ARCHITECT FREE T4 REAGENT, LOT NUMBER 73547UD00.