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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR A 14 DAY OLD PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: 13.50 TO 41.30 PMOL/L): (B)(6) 2025, SID (B)(6): INITIAL RESULT WAS >64.35 PMOL/L, REPEAT = 24.67 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

SECTION D4 EXPIRATION DATE WAS UPDATED FROM 09/30/2025 TO 09/23/2025. SECTION D4 PRIMARY UDI NUMBER WAS UPDATED FROM (B)(4). THE COMPLAINT INVESTIGATION FOR FALSE ELEVATED ALINITY I FREE T4 RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING DATA FOR THE ALINITY I FREE T4 ASSAY DID IDENTIFY AN INCREASE IN COMPLAINTS. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS IDENTIFIED FOR REAGENT LOT 68382UD00. HOWEVER, TESTING WAS PERFORMED UTILIZING A RETAINED KIT AND ALL TESTING PASSED INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LIST NUMBER. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I FREE T4 ASSAY FOR LOT 68382UD00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR A 14 DAY OLD PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER PROVIDED REFERENCE RANGE: 13.50 TO 41.30 PMOL/L): ON (B)(6) 2025, SID (B)(6): INITIAL RESULT WAS >64.35 PMOL/L, REPEAT = 24.67 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.