ELECSYS FT3 III

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE COBAS 8000 CORE UNIT IS (B)(6). THE PATIENT SAMPLE WAS REQUIRED FOR INVESTIGATION. THE PATIENT SAMPLE WAS TESTED FOR INTERFERENCE AND A PREWASH INTERFERENCE WAS DETECTED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS T4 (T4), ELECSYS FT3 III VER.2, AND ELECSYS T3 (T3) ASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH IS FOR THE ELECSYS FT3 III VER.2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH: A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS T4 (T4) ASSAY. A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS T3 (T3) ASSAY. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AS THEY DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. PLEASE REFER TO THE ATTACHMENT (B)(6) FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULTS.

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED AN INTERFERENT IN THE PATIENT SAMPLE HAD CAUSED THE EVENT. 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.