ELECSYS FT3 III

Additional Manufacturer Narrative

A SAMPLE FROM THE PATENT WAS RECEIVED FOR INVESTIGATION AND THE CUSTOMER'S RESULTS WERE REPRODUCED. AN INTERFERING FACTOR AGAINST FT3 ANTIBODY / IDIOTYPE WAS IDENTIFIED IN THIS SAMPLE. THIS INTERFERENCE IS DOCUMENTED IN PRODUCT LABELING FOR THE ASSAY: 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

SAMPLE FROM THE PATIENT WAS REQUESTED FOR FURTHER INVESTIGATION.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE THYROID RESULTS FOR ONE PATIENT FROM THE COBAS E801 ANALYZER. THE CUSTOMER REPEATED THE SAMPLE ON WAKO ACCURASEED AND ABBOTT ALINITY. THE SAMPLE WAS SUBMITTED FOR PRELIMINARY INVESTIGATION AND WAS TESTED ON A COBAS E801 ANALYZER. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL DATA. BASED ON THE RESULTS THE CUSTOMER ALLEGED A NONSPECIFIC INTERFERENCE IN ROCHE ASSAYS. THIS MDR IS FOR THE FT3 G3 ELECSYS E2G ASSAY. REFER TO THE MDR WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE FT4 G4 ELECSYS E2G ASSAY. NO INFORMATION WAS PROVIDED TO DETERMINE IF THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.