ELECSYS FT3 III

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THAT A GENERAL REAGENT ISSUE CAN BE EXCLUDED. ASSAYS FROM DIFFERENT MANUFACTURERS CAN GENERATE DIFFERENT RESULTS. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, DIFFERENCES IN REFERENCE MATERIALS, AND THE STANDARDIZATION METHODOLOGY USED. IN CASE A SAMPLE IS ANALYZED WITH DIFFERENT ANALYZERS, THE GENERATED VALUES ARE TO BE INTERPRETED IN RELATION WITH THE NORMAL REFERENCE RANGES OF THE ASSAYS OF THE DIFFERENT ANALYZERS.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 6 PATIENTS' SAMPLES TESTED WITH ELECSYS FT3 G3 V2 (FT3 III V2) ASSAY, ELECSYS TSH V2 (TSH V2) ASSAY AND ELECSYS FT4 G3 (FT4 III) ASSAY ON A COBAS 8000 E801 MODULE. FROM THE 6 SAMPLES, THERE WERE 3 DISCREPANT RESULTS FOR FT3 III V2 TEST, 1 DISCREPANT RESULT FOR TSH V2 TEST AND 3 DISCREPANT RESULTS FOR FT4 III TEST. THIS MEDWATCH WILL APPLY TO THE FT3 III V2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH V2 ASSAY AND TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 III ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLES WERE INITIALLY TESTED ON THE CUSTOMER'S E801 ANALYZER. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THE PHYSICIAN REQUESTED THE SAMPLES TO BE INVESTIGATED. 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. THE SERIAL NUMBER OF THE CUSTOMER'S E801 ANALYZER WAS 1752-03. THE TSH V2 REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE FT4 III REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE FT4 IV REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE SERIAL NUMBER OF (B)(4) ANALYZER USED FOR INVESTIGATION IS 14D9-06. THE FT3 III V2 REAGENT LOT NUMBER WAS 611920. THE EXPIRATION DATE WAS NOT PROVIDED. THE TSH V2 REAGENT LOT NUMBER WAS 674689. THE EXPIRATION DATE WAS NOT PROVIDED. THE FT4 III REAGENT LOT NUMBER WAS 630888. THE EXPIRATION DATE WAS NOT PROVIDED. THE FT4 IV REAGENT LOT NUMBER WAS 670634. THE EXPIRATION DATE WAS NOT PROVIDED. THE SERIAL NUMBER OF E411 ANALYZER USED FOR INVESTIGATION IS 65G1-25. THE FT3 III V2 REAGENT LOT NUMBER WAS 611918. THE EXPIRATION DATE WAS NOT PROVIDED. THE TSH V2 REAGENT LOT NUMBER WAS 660341. THE EXPIRATION DATE WAS NOT PROVIDED. THE FT4 III REAGENT WAS NOT USED ON E411. THE FT4 IV REAGENT LOT NUMBER WAS 663936. THE EXPIRATION DATE WAS NOT PROVIDED. ALL REAGENT LOTS WERE WITHIN THEIR LIFE-CYCLE.