ELECSYS FT3 III

Additional Manufacturer Narrative

THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION WAS NOT ABLE TO CONFIRM THE RESULTS OF THE DIFFERENT ASSAY VERSIONS OF FT3 III FROM THE INVESTIGATION LABORATORY AND AN E 801 MODULE. THE INVESTIGATION WAS ABLE TO CONFIRM THE DIFFERENT FT3 III ASSAY RESULTS FROM THE E 801 MODULE AND THE E 411 ANALYZER. THE INVESTIGATION CONFIRMED THE PRESENCE OF A SMALL BIOTINOL-DEPENDING INTERFERENCE. THE INVESTIGATION ALSO CONFIRMED THE PRESENCE OF STREPTAVIDIN INTERFERENCE. THE INVESTIGATION DETERMINED THAT THE EVENT WAS CAUSED BY THE STREPTAVIDIN INTERFERENCE FACTOR IN THE SAMPLE. 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."

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III ASSAY AND ELECSYS FT3 III VER.2 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS E 801 MODULE WITH SERIAL NUMBER (B)(4) , THE INVESTIGATION SITE'S E 411 WITH SERIAL NUMBER (B)(4) AND THE INVESTIGATION SITE'S E 801 WITH SERIAL NUMBER (B)(4). THIS MEDWATCH IS FOR THE FT3 III V2 ASSAY. PLEASE REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE FT3 III ASSAY. THE REPORTER ALLEGED THAT THE FT3 RESULT DID NOT MATCH THE PATIENT'S CLINICAL SITUATION AND THAT THE THYROID DATA WERE IMBALANCED. THE REPORTER SUSPECTS A FALSELY HIGH FT3 RESULT AND SOME NONSPECIFIC INTERFERENCE IN ROCHE ASSAYS. THE REPORTER REQUESTED MEASUREMENT OF THE PATIENT SAMPLE AT AN INVESTIGATION SITE. IT WAS ALSO SENT OUT TO AN OUTSOURCED LABORATORY. THE REPORTER WAS NOT ABLE TO PROVIDE THE DATE OF MEASUREMENT AT THE CUSTOMER SITE. THE DATE OF BLOOD SAMPLING WAS USED AS THE DATE OF THE EVENT. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. PLEASE REFER TO THE ATTACHMENT "(B)(6) " FOR THE HIGHLIGHTED QUESTIONABLE RESULTS. THE FT3 III V2 REAGENT LOT NUMBER AND THE EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE FT3 III V2 REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE'S E 411 IS 611918 WITH AN EXPIRATION DATE OF 30-MAY-2023. THE FT3 III V2 REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE'S E 801 IS 611920 WITH AN EXPIRATION DATE OF 31-MAY-2023.

Additional Manufacturer Narrative

THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION.