ELECSYS FT3 III

Additional Manufacturer Narrative

THE INITIAL REPORTER PROVIDED RESULTS FOR 3 ADDITIONAL SAMPLES FOR THE SAME PATIENT RUN ON AN E801. SAMPLE- (B)(4). TSH (IU/ML): 4.03 FT3 (PG/ML): 17.5 FT4 (NG/DL): 1.12 SAMPLE- (B)(4): TSH (IU/ML): 4.03, 3.83 FT3 (PG/ML): 17.5, 14.3 FT4 (NG/DL): 1.12, 1.17, 1.10 T3 (NG/ML):1.32 SAMPLE- (B)(4): TSH (IU/ML): 5.05 FT3 (PG/ML): 12.6 FT4 (NG/DL): 1.05 THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE BELOW SAMPLES WERE PROVIDED FOR INVESTIGATION AND THEY WERE TESTED ON AN E801 ANALYZER. THE FOLLOWING INVESTIGATION RESULTS WERE OBTAINED: SAMPLE (B)(6).: TSH (IU/ML): 4.28; TSH (IU/ML): 3.659 (MEASURED WITH ABBOTT); TSH (IU/ML): 4.75 (MEASURED WITH LUMIPULSE); FT3 (PG/ML): 16.8; FT3 (PG/ML): 3.73 (MEASURED WITH ABBOTT); FT3 (PG/ML): 16.1 (MEASURED WITH LUMIPULSE); FT4 (NG/DL): 1.18; FT4 (NG/DL): 1.12; FT4 (NG/DL): 0.94 (MEASURED WITH ABBOTT); FT4 (NG/DL): 1.04 (MEASURED WITH LUMIPULSE). SAMPLE (B)(6): TSH (IU/ML): 3.83; FT3 (PG/ML): 14.3; FT3 (PG/ML): 11.2 (MEASURED WITH LUMIPULSE); FT4 (NG/DL): 1.17; FT4 (NG/DL): 0.92 (MEASURED WITH LUMIPULSE); FT4 (NG/DL): 1.10; T3 (NG/ML): 1.32; T3 (NG/ML): 0.75 (MEASURED WITH LUMIPULSE). INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION OBTAINED FT3 III RESULTS THAT WERE HIGHER THAN THE REFERENCE RANGE. THE INVESTIGATION PERFORMED INTERFERENCE ANALYSES. THE INVESTIGATION DETECTED AN INTERFERING FACTOR IN THE PATIENT SAMPLE AGAINST THE ASSAY ANTIBODY/IDIOTYPE. 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 COBAS E801 IMMUNOASSAY ANALYZER WAS (B)(6). QC WAS ACCEPTABLE. BASED ON THE RESULTS OF THE PEG TEST, INTERFERENCE AFFECTING THE FT3 RESULTS IS SUSPECTED. THE SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 1 PATIENT¿S SAMPLE TESTED WITH ELECSYS FT3 G3 V2 (FT3 III V2) ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER WHEN COMPARED TO A NON-ROCHE ANALYZER. ON (B)(6) 2023: INITIAL RESULT: 15 PG/ML REPEAT RESULT: 3.48 PG/ML (TESTED ON ABBOTT ARCHITECT). THE CUSTOMER COMPARED THE SAMPLE TO ANOTHER SAMPLE AFTER ADDING POLYETHYLENE GLYCOL (PEG) TREATMENT AND GOT A VALUE OF 14.22 PG/ML. THE CUSTOMER RE-TESTED THE SAME PATIENT'S SAMPLE ON THE SAME COBAS E801. THE FT3 RESULTS WERE EQUIVALENT TO THE INITIAL RESULT. THE SPECIFIC RESULT WAS NOT PROVIDED. ON (B)(6) 2023: INITIAL RESULT: 10.3 PG/ML. THE CUSTOMER BELIEVED THE ABBOTT ARCHITECT'S RESULT TO BE CORRECT.