ELECSYS FT4 III ASSAY

Additional Manufacturer Narrative

THE 8 SAMPLES UNDERWENT FURTHER INVESTIGATION. UPON FURTHER INVESTIGATION OF SAMPLES (B)(6)AN INTERFERENT AGAINST A COMPONENT OF THE REAGENT WAS CONFIRMED. THIS INTERFERENCE IS COVERED IN PRODUCT LABELING. UPON FURTHER INVESTIGATION OF SAMPLES (B)(6) A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THERE WAS AN INSUFFICIENT AMOUNT OF SAMPLE MATERIAL REMAINING FOR SAMPLE (B)(6). FROM THE INFORMATION AVAILABLE, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. ASSAYS FROM DIFFERENT MANUFACTURERS, IN THIS CASE SIEMENS, CAN GENERATE DIFFERENT RESULTS. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED AND DIFFERENCES IN REFERENCE MATERIALS AND STANDARDIZATION METHODOLOGY USED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FOR 5 OF THE PATIENT SAMPLES.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED THYROID RESULTS FOR 8 PATIENT SAMPLES TESTED FOR ELECSYS TSH (TSH), ELECSYS FT4 III (FT4 III), AND ELECSYS FT3 III (FT3 III) ON A COBAS E 801 MODULE. THE 8 PATIENT SAMPLES WERE SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED FOR TSH, FT4 III AND FT3 III BETWEEN THE CUSTOMER'S E801 MODULE, THE CENTAUR METHOD, AN E801 MODULE USED AT THE INVESTIGATION SITE, A COBAS 8000 E 602 MODULE USED AT THE INVESTIGATION SITE AND A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE. IT IS NOT KNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER FT4 III. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III ERRONEOUS RESULTS AND MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH ERRONEOUS RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE CUSTOMER'S E801 MODULE SERIAL NUMBER WAS (B)(4). THE E602 MODULE SERIAL NUMBER WAS (B)(4). THE E411 ANALYZER SERIAL NUMBER WAS (B)(4). THE E801 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE FT4 III REAGENT LOT NUMBER USED WITH THE E602 MODULE AND THE E411 ANALYZER WAS 378826 WITH AN EXPIRATION DATE OF 31-AUG-2019. THE FT4 III REAGENT LOT NUMBER USED WITH THE E801 MODULE AT THE INVESTIGATION SITE WAS 380330 WITH AN EXPIRATION DATE OF 31-DEC-2019.