ELECSYS FT3 III

Additional Manufacturer Narrative

SAMPLE FROM THE PATIENT WAS INVESTIGATED AND AN INTERFERING FACTOR TO THE ASSAY COMPONENTS WAS DETECTED. PRODUCT LABELING FOR THE ASSAY STATES: IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS.

Additional Manufacturer Narrative

ADDITIONAL DATA WAS PROVIDED FOR THE PATIENT SAMPLE. THE SAMPLE WAS SENT TO AN OUTSOURCED LABORATORY FOR ADDITIONAL TESTING AND WAS TESTED FOR SUBMITTED FOR PRELIMINARY INVESTIGATION BY COMPETITOR METHODS. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. SAMPLE FROM THE PATIENT WAS REQUESTED FOR FURTHER INVESTIGATION.

Additional Manufacturer Narrative

THE ANTI-TPO RESULT FROM THE COBAS 6000 E601 MODULE AS PART OF THE INVESTIGATION WAS ACTUALLY 550.4/538.7 IU/ML, NOT <30 IU/ML.

Additional Manufacturer Narrative

**UDI RELATED DATA QUALITY UPDATES ONLY** D3 IS THE INITIAL DISTRIBUTOR IN THE US.

Additional Manufacturer Narrative

THE COBAS 6000 E601 SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE THYROID RESULTS FOR ONE PATIENT FROM THE COBAS 6000 E601 MODULE COMPARED TO AN ABBOTT ARCHITECT ANALYZER. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THIS MEDWATCH IS FOR THE FT3 G3 ELECSYS ASSAY. REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE FT4 G4 ELECSYS ASSAY. NO INFORMATION WAS PROVIDED TO DETERMINE IF THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.