ELECSYS FT4 II ASSAY

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER STATED THAT THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TSH ASSAY, ELECSYS FT3 III, AND THE ELECSYS FT4 III ASSAY ON A COBAS 8000 E 801 MODULE. THE SAMPLE ALSO HAD A DISCREPANT VALUE WHEN TESTED WITH THE ELECSYS FT4 II ASSAY ON A SECOND E 801 ANALYZER THAT WAS USED FOR INVESTIGATION. THE RESULTS MEASURED ON THE REPORTER'S ANALYZER WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE FT4II ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4III ASSAY. THE SAMPLE WAS TESTED AT THE CUSTOMER SITE ON (B)(6) 2019. THE SAMPLE WAS REPEATED ON AN ABBOTT ARCHITECT ANALYZER. THE SAMPLE WAS ALSO PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED ON A SECOND E 801 ANALYZER ON (B)(6) 2019. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE SERIAL NUMBER OF THE REPORTER'S E 801 ANALYZER IS (B)(4). THE SERIAL NUMBER OF THE E 801 ANALYZER USED FOR INVESTIGATION IS (B)(4).

Additional Manufacturer Narrative

THE CUSTOMER SENT THE PATIENT SAMPLE TO THE MANUFACTURER FOR INVESTIGATION. THE CUSTOMER'S FT3, FT4 II, AND TSH RESULTS WERE REPRODUCED. THE DIFFERENCES OF THE TSH AND FT4 VALUES, GENERATED WITH THE DIFFERENT TYPES OF ANALYZERS, ARE CAUSED BY DIFFERENCES OF THE SETUPS OF THE ASSAYS, THE ANTIBODIES USED AND DIFFERENCES OF THE STANDARDIZATION MATERIALS AND PROCEDURES USED.