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. COMPLETE ENTRY SECTION E1 - ADDRESS 1 = (B)(6). SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P70, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US WITH THE SAME LIST NUMBER, AND A 510K/PMA/BLA NUMBER OF K173122.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR 3 PATIENTS. THE SAMPLES WERE REPEATED WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) 30-YEAR-OLD FEMALE PATIENT ALINITY INITIAL FT4 RESULT = 27.01 REPEAT RESULT = 13.45. SID (B)(6) 43-YEAR-OLD FEMALE PATIENT ALINITY INITIAL FT4 RESULT = 38.6 REPEAT RESULT = 13.51. SID (B)(6) 55-YEAR-OLD MALE PATIENT ALINITY INITIAL FT4 RESULT = 27.01 REPEAT RESULT = 17.01. REFERENCE RANGE IS 9.01-19.05 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.