ELECSYS FT3 III

Additional Manufacturer Narrative

THE PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION. THE INVESTIGATION FOUND THAT THE PATIENT SAMPLE CONTAINS AN INTERFERING FACTOR AGAINST THE STREPTAVIDIN COMPONENT OF THE FT3III ASSAY. THIS INTERFERENCE IS COVERED IN PRODUCT LABELING. 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." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III VER.2 RESULTS FOR 1 PATIENT SAMPLE ON 2 COBAS E 801 MODULES AND A COBAS E 411 IMMUNOASSAY ANALYZER COMPARED TO AN ABBOTT ARCHITECT. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER'S E801 ANALYZER SERIAL NUMBER IS 16Z3-08. THE CUSTOMER'S FT3 REAGENT LOT AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE INVESTIGATIONAL E801 ANALYZER SERIAL NUMBER IS 14D9-06. THE INVESTIGATION E801'S FT3 REAGENT LOT USED IS 611920. THE INVESTIGATIONAL E411 ANALYZER SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED. THE INVESTIGATIONAL E411'S FT3 REAGENT LOT AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

Additional Manufacturer Narrative

THE SAMPLE WAS SUBMITTED FOR INTERFERENCE TESTING. THE INVESTIGATION IS ONGOING. H3 OTHER TEXT : NA.