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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P70-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P70, WITH 510K/PMA/BLA NUMBER K173122.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR ONE 56 YEAR OLD FEMALE PATIENT. THE SAMPLE WAS REPEATED WITH A LOWER RESULT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), INITIAL RESULT = 20.81 PMOL/L REPEAT RESULT = 13.53 PMOL/L REFERENCE RANGE IS 9.01-19.05 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.