ELECSYS FT3 III

Additional Manufacturer Narrative

FURTHER INVESTIGATIONS OF THE PATIENT SAMPLE COULD NOT DUPLICATE THE RESULTS OBTAINED BY THE CUSTOMER. THE PRESENCE OF AN INTERFERING FACTOR AGAINST THE ASSAY ANTIBODY IDIOTYPE OR STREPTAVIDIN CAN BE EXCLUDED. THE VALUE DIFFERENCES OBTAINED WITH THE DIFFERENT ASSAYS RELATE TO THE DIFFERENCES IN THE SETUP OF THE ASSAYS, THE ANTIBODIES USED, AND DIFFERENCES IN THE STANDARDIZATION MATERIALS AND PROCEDURES USED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM.

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 ANALYTICAL UNIT ANALYZERS AND A COBAS E 411 ANALYZER. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E 801 ANALYZER ON (B)(6) 2023. THE SAMPLE WAS REPEATED USING THE WAKO ACCURASEED METHOD. THE CUSTOMER ALSO TREATED THE SAMPLE WITH A 25 % POLYETHYLENE GLYCOL (PEG) SOLUTION AND RE-MEASURED IT ON THE E 801 ANALYZER. THE SAMPLE WAS PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED ON A SECOND E 801 ANALYZER AND AN E411 ANALYZER ON (B)(6) 2023. THE SAMPLE WAS ALSO REPEATED WITH THE ABBOTT ARCHITECT METHOD ON (B)(6) 2023.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER E 801 ANALYZER WAS REQUESTED, BUT NOT PROVIDED. 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 WAS 14D9-06. FT3 REAGENT LOT NUMBER 669112, WITH AN EXPIRATION DATE OF 28-FEB-2024 WAS USED ON THIS ANALYZER. THE SERIAL NUMBER OF THE E411 ANALYZER USED FOR INVESTIGATION WAS 65G1-25. FT3 REAGENT LOT NUMBER 669112, WITH AN EXPIRATION DATE OF 28-FEB-2024 WAS USED ON THIS ANALYZER. THE INVESTIGATION IS ONGOING.