ARCHITECT FREE T4

Additional Manufacturer Narrative

SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07K65-78 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07K65, WITH 510K/PMA/BLA NUMBER K173122. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY DEPRESSED ARCHITECT FREE T4 RESULT FOR ONE PATIENT. THE SAMPLE WAS REPEATED WITH HIGHER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT = 8.56 REPEAT RESULT SID FF155 = 13.10 PMOL/L. REFERENCE RANGE = 9.09-19.04 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.