ELECSYS T4 ASSAY

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

Description of Event or Problem

THE CUSTOMER COMPLAINED ABOUT THE RESULTS FOR 1 PATIENT TESTED ON MULTIPLE ASSAYS ON THE ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER. THE PATIENT WAS TESTED FOR ELECSYS FT4 II ASSAY (FT4 II), ELECSYS TSH ASSAY (TSH), ELECSYS T4 ASSAY (T4), ELECSYS T-UPTAKE ASSAY (T-UPTAKE), ELECSYS FSH ASSAY (FSH), ELECSYS T3 (T3), ELECSYS FT3 III (FT3 III), ELECSYS ESTRADIOL III ASSAY (ESTRADIOL III), ELECSYS PROGESTERONE III (PROGESTERONE III), ELECSYS PTH (1-84) PTH 1-84 AND ELECSYS FERRITIN (FERRITIN). THE PTH 1-84 ASSAY IS NOT RELEASED FOR DISTRIBUTION IN THE UNITED STATES NOR IS IT SIMILAR TO A DEVICE RELEASED FOR DISTRIBUTION IN THE UNITED STATES. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE PHYSICIAN DID NOT BELIEVE THE RESULTS. THE PATIENT IS BEING TREATED WITH 100 MG OF BIOTIN PER DAY FOR MULTIPLE SCLEROSIS. THE CUSTOMER IS WONDERING IF THE BIOTIN TREATMENT IS INTERFERING WITH THE PATIENT'S TEST RESULTS. PRODUCT LABELING STATES "SAMPLES SHOULD NOT BE TAKEN FROM PATIENTS RECEIVING THERAPY WITH HIGH BIOTIN DOSES (I.E. > 5 MG/DAY) UNTIL AT LEAST 8 HOURS FOLLOWING THE LAST BIOTIN ADMINISTRATION." THE CUSTOMER REPEATED THE PATIENT SAMPLE AFTER TREATING IT WITH A STREPTAVIDIN COATED BEAD TREATMENT. THE PROCEDURE USED BY THE CUSTOMER IS UNKNOWN. THE FT4 II, TSH, T4, T-UPTAKE, T3, FT3 III, ESTRADIOL III AND FERRITIN RESULTS WERE DISCREPANT WHEN COMPARED TO THE RESULTS INITIALLY RELEASED FROM THE LABORATORY. REFER TO MEDWATCHES WITH THE FOLLOWING PATIENT IDENTIFIERS FOR THE AFFECTED ASSAYS: (B)(6). REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E170 ANALYZER SERIAL NUMBER WAS (B)(4). THE DISCREPANT RESULTS GENERATED DURING THE CUSTOMER'S EXPERIMENT WERE CONSISTENT WITH PATIENTS BEING TREATED WITH HIGH BIOTIN DOSAGES. AS NO SAMPLE MATERIAL WAS LEFT, AN INVESTIGATION OF THE SAMPLE MATERIAL COULD NOT BE COMPLETED. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.