ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY DEPRESSED ALINITY I FREE T4 RESULT FOR 2-MONTH-OLD MALE PEDIATRIC PATIENT. THE PATIENT HAS A HISTORY OF CONGENITAL CMV AND COMPLETED TREATMENT WITH VALGANCICLOVIR. (CUSTOMER PROVIDED REFERENCE RANGE FOR CHILD: 11.40¿21.90 PMOL/L). (B)(6) 2026 SID (B)(6) INITIAL RESULT = 10.7 PMOL/L. ADDITIONAL LAB RESULT PROVIDED: TSH RESULT = 1.26 MIU/L WITHIN NORMAL RANGE (0.35¿4.94 MIU/L). (B)(6) 2026 SID (B)(6) PATIENT TESTED AT ANOTHER LABORATORY FREE T4 RESULT = 14.54 PMOL/L, NORMAL TSH RESULT (NO SPECIFIC RESULT PROVIDED). ON (B)(6) 2026 NEW SAMPLE FREE T4 RESULT WITH SID (B)(6) = 10.97 PMOL/L, (NEW REFERENCE RANGE. DUE TO PATIENT AGE FOR FREE T4: 9.36¿14.49 PMOL/L) WITHIN NORMAL RANGE. ADDITIONAL LAB RESULT PROVIDED: TSH 1.60 MIU/ML WITHIN NORMAL RANGE (0.35¿4.94 MIU/L). SAMPLE WITH SID (B)(6) WAS FROZEN AND RETESTED ON (B)(6) 2026 ON (B)(6) WITH A RESULT = 12.34 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.