ELECSYS FT4 III ASSAY

Additional Manufacturer Narrative

THE EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TSH ASSAY, ELECSYS FT4 III ASSAY, AND ELECSYS FT3 III FOR THREE PATIENTS. OF THE DATA, ONLY ONE PATIENT HAD DISCREPANT FT4 RESULTS. THIS MEDWATCH WILL COVER FT4 III. FOR INFORMATION ON FT3 III REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). FOR INFORMATION ON TSH REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). IT WAS UNKNOWN IF ANY OF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE COBAS E801 SERIAL NUMBER FROM THE INVESTIGATION SITE WAS (B)(4). THE FT3 III REAGENT LOT USED ON THIS INSTRUMENT WAS 348359 EXPIRATION DATE OF 31-OCT-2019. THE TSH REAGENT LOT USED ON THIS INSTRUMENT WAS 331814 EXPIRATION DATE OF 31-AUG-2019. THE COBAS E411 SERIAL NUMBER FROM THE INVESTIGATION SITE WAS (B)(4). THE FT3 III REAGENT LOT USED ON THIS INSTRUMENT WAS 314666 EXPIRATION DATE OF 28FEB-2019. THE TSH REAGENT LOT USED ON THIS INSTRUMENT WAS 349487 EXPIRATION DATE OF 30-APR-2019. THE COBAS E602 SERIAL NUMBER FROM THE INVESTIGATION SITE WAS (B)(4). THE FT3 III REAGENT LOT USED ON THIS INSTRUMENT WAS 341685 EXPIRATION DATE OF 30-JUN-2019. THE TSH REAGENT LOT USED ON THIS INSTRUMENT WAS 349487 EXPIRATION DATE OF 30-APR-2019. FOR PATIENT ID (B)(6), THERE WAS INSUFFICIENT SAMPLE REMAINING FOR FURTHER INVESTIGATION. FOR PATIENT ID (B)(6) AND PATIENT ID (B)(6), THE OVERALL RESULTS BETWEEN THE ROCHE AND SIEMENS CENTAUR METHODS WERE VERY SIMILAR AND MOSTLY IN CONCORDANCE WITH EACH OTHER. THE OBSERVED DIFFERENCES IN FT3 VALUES ARE MOST LIKELY EXPLAINED BY THE FACT THAT THE 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 AND THE STANDARDIZATION METHODOLOGY USED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.