ELECSYS FT3 III

Additional Manufacturer Narrative

INVESTIGATIONS OF THE PATIENT SAMPLE DETERMINED IT CONTAINS AN INTERFERING FACTOR AGAINST THE RUTHENIUM COMPONENT OF THE FT3 ASSAY. PER 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." FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III, ELECSYS FT4 IV, AND ELECSYS ANTI-TSHR ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE RESULTS MEASURED ON THE E 801 ANALYZER DID NOT COMPARE TO RESULTS MEASURED USING THE ABBOTT METHODS. THIS MEDWATCH WILL APPLY TO THE FT3 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 ASSAY AND REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-TSHR ASSAY. THE RESULTS MEASURED ON THE E 801 ANALYZER ARE AS FOLLOWS: FT3 = 12.2 PMOL/L (REFERENCE RANGE = 3.1 - 6.8 PMOL/L), FT4 = 59.9 PMOL/L (REFERENCE RANGE = 12 - 22 PMOL/L), ANTI-TSHR TESTED ON (B)(6) 2025 = 14.00 IU/L (POSITIVE). THE RESULTS MEASURED USING THE ABBOTT METHOD ARE AS FOLLOWS: FT3 = 4.08 PMOL/L (REFERENCE RANGE = 3.45 - 5.5 PMOL/L), FT4 = 14.08 PMOL/L (REFERENCE RANGE = 11.0 - 17.7 PMOL/L), ANTI-TSHR TESTED ON (B)(6) 2025 = <0.7 IU/L (NEGATIVE).

Additional Manufacturer Narrative

MEDWATCH FIELD E1. FACILITY NAME - (B)(6). THE PATIENT'S SAMPLE WAS PROVIDED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.