ELECSYS FT3 III

Additional Manufacturer Narrative

SAMPLE 1 WAS PROVIDED FOR INVESTIGATION ON 19-OCT-2023. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

THE MEDICAL DEVICE PROBLEM CODE WAS UPDATED. THE INVESTIGATION IDENTIFIED AN INTERFERING FACTOR AGAINST THE STREPTAVIDIN 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.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS FT3 G3 V2 (FT3 III V2) ASSAY ON A COBAS 8000 E801 MODULE. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLES WERE INITIALLY TESTED ON THE CUSTOMER'S E801 ANALYZER AND REPEATED ON THE SAME ANALYZER. THE SAMPLES WERE THEN PROVIDED FOR INVESTIGATION WHERE THEY TESTED ON A 2ND E801 ANALYZER AND ON E411 ANALYZER. THE SAMPLES WERE ALSO REPEATED ON AN ABBOTT ARCHITECT ANALYZER.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S E801 ANALYZER WAS (B)(6). THE FT3 III V2 REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE SERIAL NUMBER OF E801 ANALYZER USED FOR INVESTIGATION IS (B)(6). THE FT3 III V2 REAGENT LOT NUMBER WAS 669112 WITH AN EXPIRATION DATE OF 01-FEB-2024. THE SERIAL NUMBER OF E411 ANALYZER USED FOR INVESTIGATION IS (B)(6). THE FT3 III V2 REAGENT LOT NUMBER WAS 686656 WITH AN EXPIRATION DATE OF 01-APR-2024. INVESTIGATION IS ONGOING.