ELECSYS T4 ASSAY

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER QUESTIONED RESULTS FOR 1 PATIENT TESTED FOR ELECSYS T4 (T4) AND ELECSYS (TSH) ON A COBAS E801 MODULE. THE PATIENT HAD A THYROID GLAND RESECTION IN 2009 DUE TO STRUMA MULTINODOSA. THE RESULTS FROM A THYROID SCINTIGRAPHY CONFIRM A SMALL AMOUNT OF RESIDUAL THYROID TISSUE. THE PATIENT HAS A FAMILY HISTORY OF THYROID HORMONE RESISTANCE WITH AUTOSOMAL DOMINANT INHERITANCE. THE PATIENT IS TREATED INTRAVENOUSLY WITH 2MG OF L-THYROXINE PER DAY. THE PATIENT IS CLINICALLY CONSIDERED TO HAVE HYPOTHYROIDISM. THE CUSTOMER IS CONCERNED THAT THE TSH RESULTS ARE ALWAYS HIGH AND THE T4 RESULTS ARE LOW. THIS MEDWATCH WILL COVER T4. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH RESULTS. REFER TO ATTACHED DATA FOR THE PATIENT RESULTS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E801 MODULE SERIAL NUMBER WAS (B)(4). THE CUSTOMER STATED CALIBRATION AND QC RESULTS WERE WITHIN THE ACCEPTABLE RANGES WITH NO ISSUES. THE CUSTOMER IS WONDERING IF THERE IS AN INTERFERENCE IN THE PATIENT SAMPLE AFFECTING THE RESULTS.