ELECSYS FT3 III

Additional Manufacturer Narrative

THE DIFFERENCES IN THE FT4 AND FT3 VALUES GENERATED WITH THE DIFFERENT ASSAYS RELATE TO DIFFERENCES IN THE SETUPS OF THE ASSAYS, THE ANTIBODIES USED, DIFFERENCES IN THE STANDARDIZATION MATERIALS, AND DIFFERENCES IN THE STANDARDIZATION PROCEDURES USED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S E 801 ANALYZER WAS REQUESTED, BUT NOT PROVIDED. THE FT3 III 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) . THE FT3 III REAGENT LOT NUMBER WAS 669112, WITH AN EXPIRATION DATE OF 28-FEB-2024.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH THYROID ASSAYS ON TWO COBAS 8000 E 801 MODULE ANALYZERS. RESULTS FOR THE FOLLOWING ASSAYS WERE AFFECTED: ELECSYS TSH, ELECSYS FT3 III, ELECSYS FT4 III, AND ELECSYS FT4 IV. THIS MEDWATCH WILL APPLY TO THE FT3 III ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 III ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 IV ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. VALUES HIGHLIGHTED IN YELLOW ARE QUESTIONED. SAMPLE ID (B)(6) WAS INITIALLY TESTED AT THE CUSTOMER SITE ON (B)(6) 2023. THE SAMPLE WAS ALSO TREATED WITH A 25 % POLYETHYLENE GLYCOL (PEG) SOLUTION AND REPEATED ON THE CUSTOMER'S E 801 ANALYZER. THE SAMPLE WAS REPEATED USING THE WAKO ACCURASEED METHOD. SAMPLE ID (B)(6) WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON A SECOND E 801 ANALYZER ON (B)(6) 2023. THE SAMPLE WAS ALSO REPEATED ON AN ABBOTT ARCHITECT ANALYZER. SAMPLE ID (B)(6) WAS TESTED AT THE CUSTOMER SITE ON (B)(6) 2023. THIS SAMPLE WAS REPEATED USING THE WAKO ACCURASEED METHOD. THIS SAMPLE WAS ALSO PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON A SECOND E 801 ANALYZER ON (B)(6) 2023.