ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. A1 PATIENT IDENDIFER: COMPLETE SAMPLE ID IS (B)(6).

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 (FT4) RESULT FOR A FEMALE PATIENT IN HER 30S WITH A MEDICAL HISTORY OF GRAVE¿S DISEASE AND IS CURRENTLY ON THYRADIN (THYROID HORMONE REPLACEMENT MEDICATION) GENERATED ON THE ALINITY I PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: PREVIOUS FT4 RESULT (TESTED IN (B)(6) 2024) = 1.30 NG/DL. ON (B)(6) 2025, SID (B)(6): INITIAL FT4 RESULT = 2.16 NG/DL (DUE TO THE PREVIOUS VALUE, THE CUSTOMER RETESTED THE SAMPLE) REPEAT FT4 RESULTS: FIRST REPEAT (SID 84) = 1.41 NG/DL; SECOND REPEAT (SID 84-2) = 1.35 NG/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, REVIEW OF THE DEVICE HISTORY RECORD, IN-HOUSE TESTING OF A RETAINED KIT OF THE COMPLAINT LOT, AND FIELD DATA REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING DATA IDENTIFIED AN INCREASE IN COMPLAINTS FOR THE ALINITY I FREE T4 ASSAY AS WELL AS AN INCREASE IN COMPLAINT ACTIVITY FOR REAGENT LOT 78042UD0. HOWEVER, TESTING WAS PERFORMED UTILIZING RETAINED KITS OF THE COMPLAINT LOT AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOTS ARE PERFORMING AS EXPECTED. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT 78042UD0 AND THE COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF ALINITY I FREE T4 REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE MEDIAN POPULATION RESULT FOR THE COMPLAINT LOT 78042UD00 IS WITHIN ESTABLISHED LIMITS, INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY IN THE FIELD. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I FREE T4 REAGENT LOT 78042UD0 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 (FT4) RESULT FOR A FEMALE PATIENT IN HER 30S WITH A MEDICAL HISTORY OF GRAVE¿S DISEASE AND IS CURRENTLY ON THYRADIN (THYROID HORMONE REPLACEMENT MEDICATION) GENERATED ON THE ALINITY I PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED: PREVIOUS FT4 RESULT (TESTED IN (B)(6) 2024) = 1.30 NG/DL. ON (B)(6) 2025, SID (B)(6): INITIAL FT4 RESULT = 2.16 NG/DL (DUE TO THE PREVIOUS VALUE, THE CUSTOMER RETESTED THE SAMPLE). REPEAT FT4 RESULTS: FIRST REPEAT (SID 84) = 1.41 NG/DL; SECOND REPEAT (SID 84-2) = 1.35 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.