ELECSYS FT3 III

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S COBAS E 801 MODULE WAS REQUESTED BUT NOT PROVIDED. THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III VER.2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 MODULE. THE DATE THE INFORMATION WAS RECEIVED WAS USED AS THE DATE OF EVENT. THE PATIENT SAMPLE WAS SENT TO AN INVESTIGATION LABORATORY THAT USES A COBAS E 801 MODULE AND A COBAS E 411 ANALYZER. IT WAS ALSO SENT TO AN OUTSOURCED LABORATORY THAT USES AN ABBOTT ARCHITECT. PLEASE REFER TO THE ATTACHMENT (B)(6) FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULT AND RESULTS FROM THE TWO OTHER LABORATORIES.

Additional Manufacturer Narrative

THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION TESTED THE PATIENT SAMPLE FOR THE PRESENCE OF INTERFERENCE. THE INVESTIGATION DETECTED THE PRESENCE OF AN INTERFERENT AGAINST THE ASSAY'S ANTIBODY/IDIOTYPE ON FT3. 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 DETERMINED THE EVENT WAS CAUSED BY THE PRESENCE OF AN INTERFERENT IN THE PATIENT SAMPLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.