ELECSYS FT3 III

Additional Manufacturer Narrative

THE SAMPLE WAS SUBMITTED FOR INVESTIGATION. THE CUSTOMER'S FT3 RESULTS ABOVE THE REFERENCE RANGE COULD NOT BE REPRODUCED DURING THE INVESTIGATION. FURTHER INVESTIGATION OF THE PATIENT SAMPLE CONFIRMED AN INTERFERING FACTOR AGAINST THE MONOCLONAL ANTIBODY OF THE FT3 ASSAY. THIS INTERFERENCE CAUSED THE HIGH FT3 RESULTS. AN INTERFERING FACTOR AGAINST STREPTAVIDIN COULD BE EXCLUDED. THIS INTERFERENCE IS COVERED IN PRODUCT LABELING. PRODUCT LABELING 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." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 MODULE COMPARED TO AN ACCURASEED WAKO ANALYZER. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E801 ANALYZER SERIAL NUMBER IS (B)(4).

Additional Manufacturer Narrative

AN INTERFERING SUBSTANCE IS SUSPECTED IN THE PATIENT SAMPLE. THE INVESTIGATION IS ONGOING.