ELECSYS FT3 III

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH ELECSYS FT4 G3 (FT4 III) ASSAY AND ELECSYS FT3 G3 (FT3 III) ASSAY ON A COBAS 8000 E601 MODULE. THE SAMPLE ALSO HAD DISCREPANT RESULTS WHEN TESTED ON OTHER ROCHE PLATFORMS. THIS MEDWATCH WILL APPLY TO THE FT3 III ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER PT-0065372 FOR INFORMATION RELATED TO THE FT4 III ASSAY. REFER TO THE ATTACHMENT FOR THE PATIENT'S DATA. THE SAMPLE WAS INITIALLY TESTED ON AN E601 ANALYZER. THE SAMPLE WAS THEN TESTED ON OTHER ROCHE PLATFORMS. THE SAMPLE WAS ALSO REPEATED ON BECKMAN AND SIEMENS ANALYZERS.

Additional Manufacturer Narrative

THE COBAS 6000 E601 MODULE SERIAL NUMBER WAS (B)(6). THE SERIAL NUMBERS OF OTHER ROCHE ANALYZERS WERE NOT PROVIDED. THE FT4 III REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FT3 REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE SAMPLE WAS REQUESTED FOR INVESTIGATION. ASSAYS FROM DIFFERENT MANUFACTURERS CAN GENERATE DIFFERENT RESULTS. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, DIFFERENCES IN REFERENCE MATERIALS, AND THE STANDARDIZATION METHODOLOGY USED. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE INVESTIGATION OF THE PROVIDED SAMPLE DETECTED AN INTERFERING FACTOR AGAINST THE RUTHENIUM COMPONENT OF THE ASSAY. THIS INTERFERENCE CAUSED THE HIGH FT3 III RESULTS. THE 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.