ELECSYS FT3 III

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT4 III, ELECSYS FT4 IV AND ELECSYS FT3 III VER.2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS E 801 MODULE WITH SERIAL NUMBER (B)(6) AND THE INVESTIGATION SITE'S COBAS E 801 MODULE WITH SERIAL NUMBER (B)(6). THIS MDR IS FOR THE FT3 III V2 ASSAY. REFER TO: MEDWATCH WITH A1 - PATIENT IDENTIFIER (B)(6) FOR THE FT4 IV ASSAY. MEDWATCH WITH A1 - PATIENT IDENTIFIER (B)(6) FOR THE FT4 III ASSAY. THE DATE THE INFORMATION WAS RECEIVED WAS USED AS THE DATE OF THE EVENT. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN REQUESTED THAT THE SAMPLE BE SENT TO THE INVESTIGATION SITE. THE PATIENT SAMPLE WAS THEN SENT TO THE INVESTIGATION SITE THAT USES A COBAS E 801. IT WAS ALSO SENT TO AN OUTSOURCED LABORATORY THAT USES A FUJIREBIO LUMIPULSE ANALYZER. PLEASE REFER TO THE ATTACHMENT IN THE MEDWATCH (B)(6) FOR THE HIGHLIGHTED QUESTIONABLE RESULTS.

Additional Manufacturer Narrative

THE FT3 III V2 REAGENT LOT NUMBER USED AT THE CUSTOMER SITE'S E 801 WAS REQUESTED BUT NOT PROVIDED. THE FT3 III V2 REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE'S E 801 IS 669112 WITH AN EXPIRATION DATE OF 28-FEB-2024. AN INTERFERING FACTOR AGAINST THE IDIOTYPE OF THE MONOCLONAL ANTIBODY OF THE FT3III ASSAY WAS DETECTED FROM A PREVIOUS SAMPLE FROM THIS PATIENT. THE CUSTOMER REQUESTED AN ANALYSIS OF THE REPORTED PATIENT SAMPLE. THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION.

Additional Manufacturer Narrative

THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION OBTAINED FT3 III, FT4 III, AND FT4 IV ASSAY RESULTS THAT WERE HIGHER THAN THE REFERENCE RANGE. THE PATIENT SAMPLE WAS TESTED FOR INTERFERING FACTORS. THE INVESTIGATION DETECTED AN INTERFERING FACTOR AGAINST THE RUTHENIUM (RU) LABEL OF THE FT4 IV AND FT3 III ASSAYS. PRODUCT LABELING STATES "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TOANALYTE-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.