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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. 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 (FT4) RESULTS ON A 73YRS OLD MALE PATIENT. THE RESULTS PROVIDED WERE: SID (B)(6), INITIAL=3.24 NG/DL /REPEATED=1.00 NG/DL LABORATORY REFERENCE RANGE FOR FT4=0.7 TO 1.48 NG/DL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.