ELECSYS FT4 IV

Additional Manufacturer Narrative

THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE SAMPLES HAVE BEEN REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE TEST RESULTS AND A SUSPECTED INTERFERENCE FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THE AFFECTED ASSAYS ARE ELECSYS FT3 III, ELECSYS FT4, ANTI-TPO, ANTI-TG, AND ANTI-TSHR. PLEASE REFER TO THE HIGHLIGHTED PATIENT RESULTS IN THE ATTACHMENT "(B)(6). IT WAS ALLEGED THAT THE RESULTS DO NOT MATCH THE PATIENT'S CLINICAL PICTURE. THIS MEDWATCH WILL APPLY TO THE ELECSYS FT4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS FT3 III ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS ANTI-TPO ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS ANTI-TG ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS ANTI-TSHR ASSAY.