ELECSYS FT3 III

Additional Manufacturer Narrative

E1 INITIAL REPORTER ESTABLISHMENT NAME: (B)(6) HOSPITAL. E1 INITIAL REPORTER STREET LINE 1: (B)(6). THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC WERE ACCEPTABLE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 125 II RESULTS FOR 1 PATIENT SAMPLE AND QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 601 MODULE. THE INITIAL CA 125 RESULT WAS 144.3 U/ML AND THE REPEATED RESULT WAS 31.30 U/ML. ON (B)(6) 2024 THE INITIAL FT3 RESULT WAS 15.75 PMOL/L AND THE REPEATED RESULT WAS 5.07 PMOL/L. THE SAMPLES WERE REPEATED DUE TO THE INITIAL RESULT NOT MATCHING THE PATIENT'S CLINICAL DIAGNOSIS. THIS MEDWATCH WILL APPLY TO THE ELECSYS FT3 III ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS CA 125 II ASSAY.

Additional Manufacturer Narrative

SECTIONS D1-D4, G1, AND G4 WERE UPDATED AS THE REAGENT CATALOG NUMBER WAS UPDATED. IT WAS INITIALLY REPORTED THAT THE CALIBRATION AND QC WERE ACCEPTABLE. HOWEVER, THE CALIBRATION AND QC DATA WAS NOT PROVIDED. A GENERAL REAGENT ISSUE WAS EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.