ELECSYS FT3 III

Additional Manufacturer Narrative

THE SAMPLE WAS RECEIVED FOR INVESTIGATION ON 06-MAR-2024. THE INVESTIGATION REVEALED THAT THE MATHEMATICAL DIFFERENCES IN THE FT3 VALUES GENERATED WITH THE DIFFERENT ASSAYS RELATE TO DIFFERENCES IN THE SETUPS OF THE ASSAYS, THE ANTIBODIES USED, AND DIFFERENCES IN THE STANDARDIZATION MATERIALS AND PROCEDURES USED. THE PRODUCT LABELING STATES: FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S E411 ANALYZER WAS NOT PROVIDED. THE TSH V2 REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE SERIAL NUMBER OF THE E411 ANALYZER USED FOR THE INVESTIGATION WAS (B)(6). THE TSH V2 REAGENT LOT NUMBER WAS 718937 WITH AN EXPIRATION DATE OF 30-APR-2024. THE SAMPLE WAS REQUESTED FOR INVESTIGATION. ASSAYS FROM DIFFERENT MANUFACTURERS CAN GENERATE DIFFERENT RESULTS. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, DIFFERENCES IN REFERENCE MATERIALS, AND THE STANDARDIZATION METHODOLOGY USED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 1 PATIENT¿S SAMPLE TESTED WITH ELECSYS TSH V2 ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER. THE SAMPLE WAS ALSO REPEATED ON AN ABBOTT ARCHITECT ANALYZER. THIS MEDWATCH WILL APPLY TO THE FT3 III V2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH ASSAY. REFER TO THE ATTACHMENT FOR THE PATIENT¿S DATA. ON (B)(6) 2024 THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S COBAS E411 DISK. ON (B)(6) 2024 THE SAMPLE WAS RE-TESTED AT THE INVESTIGATION SITE AND OBTAINED DISCREPANT RESULTS WHEN COMPARED TO ELECSYS FT3 III V2 ASSAY. ON (B)(6) -2024 THE ORIGINAL SAMPLE WAS RE-TESTED ON AN ABBOTT ANALYZER.