ELECSYS FT4 III ASSAY

Additional Manufacturer Narrative

PATIENT SAMPLES WERE RETURNED FOR INVESTIGATION. SAMPLE (B)(6) HAD INSUFFICIENT VOLUME FOR FURTHER INVESTIGATION. FROM THE INFORMATION PROVIDED THE INVESTIGATION DETERMINED, A GENERAL REAGENT ISSUE MOST LIKELY CAN BE EXCLUDED. IT NEEDS TO BE TAKEN INTO ACCOUNT THAT ASSAYS FROM DIFFERENT VENDORS CAN GENERATE DIFFERENT VALUES. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED AND, DIFFERENCES IN REFERENCE MATERIALS/METHODS AND THE STANDARDIZATION METHODOLOGY USED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR A TOTAL OF 7 PATIENT SAMPLES TESTED WITH ELECSYS FT3 III, THE ELECSYS FT4 III ASSAY, AND THE ELECSYS TSH ASSAY ON A COBAS 8000 E 801 MODULE. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE FT4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 ASSAY AND REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH ASSAY. THE SAMPLES WERE INITIALLY TESTED AT THE CUSTOMER SITE ON (B)(6) 2019. THE SAMPLES WERE REPEATED ON A CENTAUR ANALYZER. THE SAMPLES WERE ALSO PROVIDED FOR INVESTIGATION, WHERE THEY WERE TESTED ON A COBAS 6000 E 601 MODULE ON (B)(6) 2019, A SECOND E 801 ANALYZER ON (B)(6) 2019, AND A COBAS E 411 IMMUNOASSAY ANALYZER ON (B)(6) 2019. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE E 601 ANALYZER USED FOR INVESTIGATION IS SERIAL NUMBER (B)(4). FT4 REAGENT LOT NUMBER 378826, WITH AN EXPIRATION DATE OF 31-AUG-2019 WAS USED ON THIS ANALYZER. THE E 801 ANALYZER USED FOR INVESTIGATION IS SERIAL NUMBER (B)(4). FT4 REAGENT LOT NUMBER 380330, WITH AN EXPIRATION DATE OF 31-DEC-2019 WAS USED ON THIS ANALYZER. THE E 411 ANALYZER USED FOR INVESTIGATION IS SERIAL NUMBER (B)(4). FT4 REAGENT LOT NUMBER 378826, WITH AN EXPIRATION DATE OF 31-AUG-2019 WAS USED ON THIS ANALYZER.