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.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I FREE T4 GENERATED FROM ALINITY I PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA: SAMPLE ID (B)(6), THE INITIAL RESULT WAS > 5.00 NG/DL AND REPEAT RESULT WAS 1.36 NG/DL. THE CUSTOMER PROVIDED ADDITIONAL LABORATORY DATA: TSH: WAS 0.4590 UIU/ML & 0.4560 UIU/ML FREE T3: WAS 3.13 PG/ML & 2.73 PG/ML TRAB: WAS 1.10 IU/L TG WAS 14.24 NG/ML. HISTORICAL TSH VALUES: THE CUSTOMER COMMUNICATED THAT THE PATIENT'S TSH LEVELS ARE IMPROVING OVER THE PAST SIX MONTHS: 0.2 , 0.4 , 0.5. PATIENT INFORMATION: 80-YEAR-OLD MALE WITH A MEDICAL HISTORY OF PSVT (PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA) AND HYPERTHYROIDISM. MEDICATIONS: THIAMAZOLE & WARFARIN THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.