ELECSYS FT3 III

Additional Manufacturer Narrative

THE INVESTIGATION TESTED THE PATIENT SAMPLE ON A COBAS E 801 MODULE. THE FT3 III RESULT WAS 12.3 PMOL/L. THE INVESTIGATION PERFORMED INTERFERENCE ANALYSES. THE INVESTIGATION CONFIRMED THE PRESENCE OF AN INTERFERING FACTOR AGAINST THE IDIOTYPE STRUCTURE OF THE FT3 III MONOCLONAL ANTIBODY OF THE ASSAY. 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.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE FIRST E 801 IS (B)(6). THE SERIAL NUMBER OF THE SECOND E 801 WAS NOT PROVIDED. THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III RESULT FROM ONE PATIENT SAMPLE TESTED ON TWO COBAS E 801 ANALYTICAL UNITS. THE INITIAL RESULT WAS REPORTED TO THE PATIENT. THE REPORTER WOULD LIKE TO VERIFY IF THE RESULTS FROM THE E 801 WERE FALSELY HIGH RESULTS. THE PATIENT SAMPLE WAS ALSO RERUN ON AN ABBOTT ANALYZER. ON 12-JUL-2023, THE INITIAL RESULT FROM THE FIRST E 801 WAS 9.01 PG/ML. ON 13-JUL-2023, THE REPEAT RESULT FROM THE SECOND E 801 WAS 8.50 PG/ML. THE REPEAT RESULT FROM THE ABBOTT ANALYZER WAS LESS THAN 1.07 PG/ML.