ELECSYS FT3 III

Additional Manufacturer Narrative

FURTHER INVESTIGATIONS PERFORMED WITH THE PATIENT SAMPLE DID NOT FIND ANY EVIDENCE OF A FACTOR THAT INTERFERES WITH A COMPONENT OF THE FT3 ASSAY. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT´S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE.

Additional Manufacturer Narrative

**UDI RELATED DATA QUALITY UPDATES ONLY** D3 IS THE INITIAL DISTRIBUTOR IN THE US.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S E 801 ANALYZER WAS (B)(6). THE FT3 REAGENT LOT NUMBER AND EXPIRATION DATE USED ON THIS ANALYZER WERE REQUESTED, BUT NOT PROVIDED. THE SERIAL NUMBER OF THE E 801 ANALYZER USED FOR INVESTIGATION IS (B)(6). FT3 REAGENT LOT 669112, WITH AN EXPIRATION DATE OF 29-FEB-2024 WAS USED ON THIS ANALYZER. THE SERIAL NUMBER OF THE E 411 ANALYZER USED FOR INVESTIGATION IS (B)(6). FT3 REAGENT LOT 686656, WITH AN EXPIRATION DATE OF 30-APR-2024 WAS USED ON THIS ANALYZER. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III ON TWO COBAS E 801 MODULE ANALYZERS AND A COBAS E 411 ANALYZER. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E 801 MODULE ON (B)(6)2023. THE SAMPLE WAS REPEATED USING THE ABBOTT ALINITY AND WAKO ACCURASEED METHODS. THE SAMPLE WAS ALSO TREATED WITH A 25 % POLYETHYLENE GLYCOL (PEG) SOLUTION AND THEN REPEATED ON THE CUSTOMER'S E 801 MODULE. THE SAMPLE WAS PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED ON A SECOND E 801 ANALYZER AND AN E411 ANALYZER ON (B)(6) 2023.