ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

SECTION A.1 PATIENT IDENTIFIER REACHED CHARACTER LIMIT, THE FULL ID IS (B)(6). SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 FOR A 57-YEAR-OLD WHITE FEMALE. PATIENT HISTORY INCLUDES: RHEUMATOID ARTHRITIS, FIBROMYALGIA, IBS, ASTHMA, TYPE 2 DIABETES, HAY FEVER, ANXIETY / PANIC DISORDER AND TAKING MEDICATIONS BUDESONIDE + FORMOTEROL INHALER, CETIRIZINE, FEXOFENIDINE, FOLIC ACID, HYOSCINE BUTYLBROMIDE, IBUPROFEN, LEFLUNOMIDE, METHOTREXATE, OMEPRAZOLE, PARACETAMOL, PREDNISOLONE, SALBUTAMOL, AND SERTRALINE. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 9.0-19.1 PMOL/L): ON (B)(6) 2026, SID (B)(6), INITIAL FREE T4 RESULT= 26.10 PMOL/L; REPEAT RESULTS= 18.54 PMOL/L, 15.95 PMOL/L; (B)(6) 2026, REPEAT RESULTS= 12.31 PMOL/L, 11.32 PMOL/L ADDITIONAL RESULTS PROVIDED: PT RESULT= 9.6 (REFERENCE RANGE 9.7-12.0), INR RESULT= 0.5, APTT RESULT= 22.9. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.