ELECSYS T4 ASSAY

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE CUSTOMER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS T4 (T4) AND ELECSYS T3 (T3) ON A COBAS E801 MODULE AND A COBAS 6000 E 601 MODULE COMPARED TO THE ABBOTT METHOD. THIS MEDWATCH WILL COVER T4 ON THE E601 MODULE. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T4 RESULTS ON THE E801 MODULE, MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T3 RESULTS ON THE E801 MODULE AND MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T3 RESULTS ON THE E601 MODULE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E801 MODULE SERIAL NUMBER WAS (B)(4). THE E601 MODULE SERIAL NUMBER WAS NOT PROVIDED.

Additional Manufacturer Narrative

UPON FURTHER INVESTIGATION OF THE PATIENT SAMPLE, AN INTERFERENT AGAINST THE STREPTAVIDIN COMPONENT OF THE REAGENT WAS CONFIRMED. THIS INTERFERENCE IS COVERED IN PRODUCT LABELING: "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."