ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6). 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 OBSERVED FALSELY ELEVATED ALINITY I FREE T4 FOR MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 9.0 - 19.0 PMOL/L): (B)(6) 2025, SID (B)(4) , INITIAL FREE T4 RESULT (B)(6) >64.4 PMOL/L; REPEAT RESULT (B)(6) = 16.9 PMOL/L (B)(6) 2025, SID (B)(4) , INITIAL FREE T4 RESULT (B)(6) = 14.9; REPEAT RESULT= 19.2 PMOL/L; SAME PATIENT WAS TESTED ON SID (B)(4) , INITIAL FREE T4 RESULT(B)(6) = 28.1 PMOL/L; REPEAT RESULT (B)(6) >64.4 PMOL/L. (B)(6) 2025, SID (B)(4) , INITIAL FREE T4 RESULT (B)(6) >64.4 PMOL/L; (B)(6) 2025, FT4 RESULT= 12.1 PMOL/L. ADDITIONAL LAB RESULTS:(B)(6) 2025, TSH RESULT= 7.55; FT3 RESULT= 3. (B)(6) 2025, SID (B)(4) , DIAGNOSIS OF STROKE, TAKING AMIODARONE, INITIAL FREE T4 RESULT (AI23959)= 27.2 PMOL/L; (B)(6) 2025, FT4 RESULT= 14.6 PMOL/L. (B)(6) 2025, SID (B)(4) , INITIAL FREE T4 RESULT (B)(6) = 31.7 PMOL/L, PREVIOUS FREE T4 RESULT WAS NORMAL (B)(6) 2025, SID (B)(4) , DIAGNOSIS OF DEMENTIA, INITIAL FREE T4 RESULT (B)(6) = 27.9 PMOL/L; (B)(6) 2024, FT4 RESULT= 18.5 PMOL/L. ADDITIONAL LAB RESULT: (B)(6) 2024, TSH RESULT= 0.103 (B)(6) 2025, SID (B)(4) , INITIAL FREE T4 RESULT (B)(6) >64.4 PMOL/L; REPEAT RESULTS= 17.8 PMOL/L (B)(6) 2025, SID (B)(4) , INITIAL FREE T4 RESULT (B)(6) = 31.4 PMOL/L; REPEAT RESULTS= 15.8 PMOL/L. (B)(6) 2025, SID (B)(4) , INITIAL FREE T4 RESULT (B)(6) >64.4 PMOL/L; REPEAT RESULT= 17.7 PMOL/L. (B)(6) 2025, SID (B)(4) , INITIAL FREE T4 RESULT(B)(6) = 64.4 PMOL/L; (B)(6) 2025, FT4 RESULT= 14.3 PMOL/L; (B)(6) 2025, FT4 RESULT= 21.9 PMOL/L. ADDITIONAL RESULT PROVIDED: (B)(6) 2025, TSH RESULT= 1.02 (B)(6) 2025, SID (B)(4) , INITIAL FREE T4 RESULT (B)(6) = 20.4 PMOL/L; REPEAT RESULT= 16.4 PMOL/L. (B)(6) 2025, SID (B)(4) , PREGNANT TAKING 200MCG T4, INITIAL FREE T4 RESULT (B)(6) = 50.7 PMOL/L; (B)(6) 2025, FREE T4 RESULT= 12.2 PMOL/L. (B)(6) 2025, SID (B)(4) , INITIAL FREE T4 RESULT= 31.7 PMOL/L; REPEAT RESULT= 15.5 PMOL/L. (B)(6) 2025, SID (B)(4) , INITIAL FREE T4 RESULT= 22.2 PMOL/L; REPEAT RESULT= 13.2 PMOL/L. (B)(6) 2025, SID (B)(4) , ANTICOAGULANT MONITORING, INITIAL FREE T4 RESULT (B)(6) = 38.1 PMOL/L; REPEAT RESULTS= 16.9 PMOL/L, 17.2 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 FOR MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 9.0 - 19.0 PMOL/L): ON (B)(6) 2025, SID (B)(6), INITIAL FREE T4 RESULT (B)(6) >64.4 PMOL/L; REPEAT RESULT (B)(6)= 16.9 PMOL/L. ON (B)(6) 2025, SID (B)(6), INITIAL FREE T4 RESULT (B)(6) = 14.9; REPEAT RESULT= 19.2 PMOL/L; SAME PATIENT WAS TESTED ON SID (B)(6), INITIAL FREE T4 RESULT (B)(6) = 28.1 PMOL/L; REPEAT RESULT (B)(6) >64.4 PMOL/L. ON (B)(6) 2025, SID (B)(6), INITIAL FREE T4 RESULT (B)(6) >64.4 PMOL/L; (B)(6) 2025, FT4 RESULT= 12.1 PMOL/L. ADDITIONAL LAB RESULTS: (B)(6) 2025, TSH RESULT= 7.55; FT3 RESULT= 3. ON (B)(6) 2025, SID (B)(6), DIAGNOSIS OF STROKE, TAKING AMIODARONE, INITIAL FREE T4 RESULT (B)(6)= 27.2 PMOL/L; (B)(6) 2025, FT4 RESULT= 14.6 PMOL/L. ON (B)(6) 2025, SID (B)(6), INITIAL FREE T4 RESULT (B)(6) = 31.7 PMOL/L, PREVIOUS FREE T4 RESULT WAS NORMAL. ON (B)(6) 2025, SID (B)(6), DIAGNOSIS OF DEMENTIA, INITIAL FREE T4 RESULT (B)(6) = 27.9 PMOL/L; (B)(6) 2024, FT4 RESULT= 18.5 PMOL/L. ADDITIONAL LAB RESULT: (B)(6) 2024, TSH RESULT= 0.103. ON (B)(6) 2025, SID (B)(6), INITIAL FREE T4 RESULT (B)(6) >64.4 PMOL/L; REPEAT RESULTS= 17.8 PMOL/L, ON (B)(6) 2025, SID (B)(6), INITIAL FREE T4 RESULT (B)(6) = 31.4 PMOL/L; REPEAT RESULTS= 15.8 PMOL/L, ON (B)(6) 2025, SID (B)(6), INITIAL FREE T4 RESULT (B)(6) >64.4 PMOL/L; REPEAT RESULT= 17.7 PMOL/L, ON (B)(6) 2025, SID (B)(6), INITIAL FREE T4 RESULT (B)(6) = 64.4 PMOL/L; (B)(6) 2025, FT4 RESULT= 14.3 PMOL/L; (B)(6)2025, FT4 RESULT= 21.9 PMOL/L. ADDITIONAL RESULT PROVIDED: (B)(6) 2025, TSH RESULT= 1.02. ON (B)(6) 2025, SID (B)(6), INITIAL FREE T4 RESULT (B)(6)= 20.4 PMOL/L; REPEAT RESULT= 16.4 PMOL/L (B)(6) 2025, SID (B)(6) , PREGNANT TAKING 200MCG T4, INITIAL FREE T4 RESULT (B)(6)= 50.7 PMOL/L; (B)(6) 2025, FREE T4 RESULT= 12.2 PMOL/L (B)(6) 2025, SID (B)(6) , INITIAL FREE T4 RESULT= 31.7 PMOL/L; REPEAT RESULT= 15.5 PMOL/L, (B)(6) 2025, SID (B)(6), INITIAL FREE T4 RESULT= 22.2 PMOL/L; REPEAT RESULT= 13.2 PMOL/L, (B)(6) 2025, SID (B)(6), ANTICOAGULANT MONITORING, INITIAL FREE T4 RESULT (B)(6)= 38.1 PMOL/L; REPEAT RESULTS= 16.9 PMOL/L, 17.2 PMOL/L . 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, DEVICE HISTORY RECORD REVIEW, IN HOUSE TESTING AND LABELING REVIEW. 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. HOWEVER, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 75088UD00. ADDITIONALLY, IN HOUSE TESTING WAS PERFORMED UTILIZING RETAINED KITS OF LOT 75088UD00. ALL TESTING PASSED INDICATING THE REAGENT LOTS ARE PERFORMING AS EXPECTED. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBERS AND COMPLAINT ISSUE. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 REAGENT LOT 75088UD00 WAS IDENTIFIED.