ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

COMPLETE INFORMATION FOR SECTION A1 PATIENT IDENTIFIER IS SID (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 68-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL RANGE IS UP TO 1.22 NG/DL. SID (B)(6): ON (B)(6) 2025, INITIAL RESULT (B)(6) = 1.13 NG/DL ON (B)(6) 2025 REPEAT RESULT (B)(6) = 5.00 NG/DL REPEATED IN NORMAL RANGE. THE CUSTOMER REPEATED THE TEST ON OTHER MODULES, OBTAINING AN AVERAGE RESULT OF 1.15 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 68-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S NORMAL RANGE IS UP TO 1.22 NG/DL SID (B)(6): (B)(6) 2025 INITIAL RESULT ((B)(6)) = 1.13 NG/DL. (B)(6) 2025 REPEAT RESULT ((B)(6)) = 5.00 NG/DL REPEATED IN NORMAL RANGE. THE CUSTOMER REPEATED THE TEST ON OTHER MODULES, OBTAINING AN AVERAGE RESULT OF 1.15 NG/DL. 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 DATA IDENTIFIED AN INCREASE IN COMPLAINTS FOR THE ALINITY I FREE T4 ASSAY, AS WELL AS AN INCREASE IN COMPLAINT ACTIVITY FOR REAGENT LOT 73465UD00. HOWEVER, TESTING PERFORMED USING RETAINED KITS FROM LOT 73465UD00 SHOWED THAT ALL RESULTS PASSED, INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. A DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT OR ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I FREE T4 ASSAY, LOT 73465UD00 WAS IDENTIFIED.