ELECSYS FT3 III

Additional Manufacturer Narrative

THE INITIAL REPORT STATED THE QUESTIONABLE FT3 III RESULTS WERE "LESS THAN 50" PMOL/L. THIS SHOULD SAY: THAT THE QUESTIONABLE FT3 III RESULTS WERE "GREATER THAN 50" PMOL/L. FURTHER INVESTIGATION OF THE PATIENT SAMPLE CONFIRMED AN INTERFERENCE TO THE FT3 IDIOTYPE COMPONENT OF THE REAGENT CAUSING THE ELEVATED FT3 III RESULTS. 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." THE INVESTIGATION DETERMINED THAT NO PRODUCT PROBLEM WAS FOUND. THE REAGENT PERFORMS WITHIN SPECIFICATIONS.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT ELECSYS FT3 G3 (FT3 III) RESULTS FOR 1 PATIENT'S SAMPLE NOT MATCHING THE PATIENT'S CLINICAL DIAGNOSIS. THE SAMPLE WAS TESTED ON A COBAS 8000 COBAS E602 IMMUNOASSAY ANALYZER. REFER TO THE ATTACHMENT FOR THE PATIENT'S DATA. ON (B)(6) 2023 THE SAMPLE WAS INITIALLY TESTED. ON (B)(6) 2023 A NEW BLOOD SAMPLE WAS DRAWN AND TESTED. ON (B)(6) 2023 THE SAMPLE FROM (B)(6) 2023 WAS REPEATED.

Additional Manufacturer Narrative

THE COBAS E 602 IMMUNOANALYZER SERIAL NUMBER WAS (B)(6) . THE QC WAS PERFORMED ON THE DAYS OF THE EVENT AND THEY WERE ACCEPTABLE. INVESTIGATION IS ONGOING.