ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR AN 84-YEAR-OLD FEMALE TAKING WARFARIN DIAGNOSED WITH HEART FAILURE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2026, SID (B)(6) (FREE T4 NORMAL RANGE: 0.70 TO 1.48 NG/DL): FT4 RESULT SERUM SAMPLE = 1.88 NG/DL (RESULT BEING QUESTIONED) REPEAT TESTING AFTER RE-CENTRIFUGING SERUM SAMPLE: FT4 RESULT = 1.39 NG/DL EDTA-K2 PLASMA SAMPLE: FT4 RESULT = 1.27 NG/DL. OTHER TESTING PROVIDED BY THE CUSTOMER: TSH RESULT = 0.8232 UIU/ML, T3 RESULT = < 0.40 NG/ML, BNP RESULT = 395 PG/ML. REPEAT TESTING AFTER RE-CENTRIFUGING SERUM SAMPLE: TSH RESULT = 0.8047 UIU/ML, T3 RESULT = 0.40 NG/ML, EDTA-K2 PLASMA SAMPLE: TSH RESULT = 0.83 UIU/ML, T3 RESULT = < 0.40 NG/ML. THE CUSTOMER STATED THEY ARE ONLY QUESTIONING THE FREE T4 RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY FOR THE ALINITY I FREE T4 ASSAY (LIST NUMBER 07P70); HOWEVER, NO TRENDS WERE IDENTIFIED FOR THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF THE ALINITY I FREE T4 REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE MEDIAN POPULATION RESULT FOR THE COMPLAINT LOT 78124UD00 IS WITHIN ESTABLISHED LIMITS, INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY IN THE FIELD. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT NUMBER 78124UD00 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 78124UD00.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR AN 84-YEAR-OLD FEMALE TAKING WARFARIN DIAGNOSED WITH HEART FAILURE. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2026, SID (B)(6) (FREE T4 NORMAL RANGE: 0.70 TO 1.48 NG/DL): FT4 RESULT SERUM SAMPLE = 1.88 NG/DL (RESULT BEING QUESTIONED) REPEAT TESTING AFTER RE-CENTRIFUGING SERUM SAMPLE: FT4 RESULT = 1.39 NG/DL EDTA-K2 PLASMA SAMPLE: FT4 RESULT = 1.27 NG/DL. OTHER TESTING PROVIDED BY THE CUSTOMER: TSH RESULT = 0.8232 UIU/ML T3 RESULT = < 0.40 NG/ML BNP RESULT = 395 PG/ML REPEAT TESTING AFTER RE-CENTRIFUGING SERUM SAMPLE: TSH RESULT = 0.8047 UIU/ML T3 RESULT = 0.40 NG/ML EDTA-K2 PLASMA SAMPLE: TSH RESULT = 0.83 UIU/ML. T3 RESULT = < 0.40 NG/ML. THE CUSTOMER STATED THEY ARE ONLY QUESTIONING THE FREE T4 RESULTS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.