ELECSYS FT3 III

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 1 PATIENT¿S SAMPLE TESTED WITH ELECSYS FT4 G4 (FT4 IV) ASSAY AND FT3 G3 (FT3 III) ASSAY ON A COBAS 8000 E801 IMMUNOASSAY ANALYZER WHEN COMPARED TO A COMPETITOR'S (ABBOTT) METHOD. 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 FT4 IV ASSAY. THE PHYSICIAN QUESTIONED THE INITIAL RESULTS FOR FT4 IV AND FT3 III.

Additional Manufacturer Narrative

THE FT3 III REAGENT'S EXPIRATION DATE WAS NOT PROVIDED. THE FT4 IV REAGENTS' LOT NUMBERS USED WERE 670634 WITH AN EXPIRATION DATE OF 30-NOV-2023 AND 724974 WITH AN EXPIRATION DATE OF 31-MAY-2024. THE COBAS E801 MODULE SERIAL NUMBER WAS (B)(6). THE PATIENT'S SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE MEDICAL DEVICE PROBLEM CODE WAS UPDATED. THE SAMPLE WAS PROVIDED FOR INVESTIGATION. THE CUSTOMER'S FT4 VALUES ABOVE THE REFERENCE RANGE COULD BE REPRODUCED. A PREWASH EFFECT COULD NOT BE SEEN. THE CUSTOMER'S FT3III VALUE SLIGHTLY ABOVE THE UPPER LEVEL OF THE NORMAL REFERENCE RANGE WAS GENERATED. INTERFERENCE ANALYSIS - STREPTAVIDIN AGENT (SA) COMPONENT INTERFERENCE ANALYSIS WAS CARRIED OUT WITH SA TOOLBOX (A-TG) ON COBAS E411 TO CHECK IF AN INTERFERING FACTOR AGAINST SA (STREPTAVIDIN) COULD BE PRESENT IN THIS SAMPLE. A REAGENT WITHOUT SA-INTERFERENCE BLOCKING AGENT AND A REAGENT WITH SA-INTERFERENCE BLOCKING AGENT WERE USED FOR COMPARATIVE MEASUREMENT. THE RESULTS OF BOTH A-TG KITS WERE COMPARABLE. NO DIFFERENCE BETWEEN THE SIGNAL VALUES COULD BE SEEN. INTERFERENCE - FT4 AND FT3 WITH BPRU INTERFERENCE ANALYSIS WAS CARRIED OUT WITH FT4 AND FT3 ON COBAS E411 TO CHECK IF AN INTERFERING FACTOR AGAINST SULFORU-LABEL COULD BE PRESENT. R&D RESEARCH KITS WITH MODIFIED RU-LABEL ("OLD" TEST GENERATION) WERE USED FOR COMPARATIVE MEASUREMENT. WITHIN THIS INTERFERENCE ANALYSIS, NO INTERFERING FACTOR AGAINST SULFORU-LABEL COULD BE IDENTIFIED AS NO DIFFERENCE BETWEEN CONCENTRATION VALUES USING SALES LOTS AND USING R&D RESEARCH KITS COULD BE SEEN. AN INTERFERING FACTOR AGAINST SA AND RU-LABEL COULD BE EXCLUDED AS NO DIFFERENCE IN SIGNAL AND CONCENTRATION VALUES COULD BE OBSERVED WITH THE INVESTIGATED ASSAYS. THE INVESTIGATION OF THE SAMPLE WITH SEVERAL RESEARCH TOOLBOXES DETERMINED THAT NO ASSAY INTERFERING FACTORS FOR THE FT4IV AND FT3III ASSAYS WERE DETECTED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. 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

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