ELECSYS FT3 III
Received Jul 24, 2023 · Event occurred Jun 27, 2023
Report 1823260-2023-02428 · MDR key 17383582
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
FT3 IIICatalog number
09005803190
Lot number
ASKU, 686656
Product problems
- High Test Results
- High Test Results
Patient
41 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TSH, ELECSYS FT3 III, ELECSYS FT4 III, AND ELECSYS FT4 IV ON A COBAS E411 DISK AND A COBAS E411 RACK. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE FT3 III ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 III ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 IV ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE VALUES HIGHLIGHTED IN YELLOW ARE QUESTIONABLE. THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E411 DISK ANALYZER ON (B)(6) 2023. THE SAMPLE WAS REPEATED USING THE ABBOTT ARCHITECT METHOD. THE CUSTOMER PERFORMED ADDITIONAL DILUTION STUDY MEASUREMENTS WITH THE TSH ASSAY ON THEIR E411 DISK ANALYZER, INCLUDING 1:5, 1:10, 1:20, 1:50, AND 1:100 DILUTIONS. THE CUSTOMER ALSO TREATED THE SAMPLE WITH A 25 % POLYETHYLENE GLYCOL SOLUTION AND REPEATED TSH, FT3 III, AND FT4 III MEASUREMENTS ON THE E411 DISK ANALYZER. THE SAMPLE WAS THEN PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED USING AN E411 RACK ANALYZER ON 11-JUL-2023.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE CUSTOMER'S E411 DISK ANALYZER IS (B)(6). THE FT3 III REAGENT LOT NUMBER AND EXPIRATION DATE USED ON THIS ANALYZER WERE REQUESTED, BUT NOT PROVIDED. THE SERIAL NUMBER OF THE E411 RACK ANALYZER USED FOR INVESTIGATION IS (B)(6). THE FT3 III REAGENT LOT NUMBER USED ON THIS ANALYZER WAS 686656, WITH AN EXPIRATION DATE OF 30-APR-2024.
Additional Manufacturer Narrative
THE DIFFERENCE IN VALUES FOR THE DIFFERENT METHODS RELATES TO DIFFERENCES IN THE SETUPS OF THE ASSAYS, THE ANTIBODIES USED, AND DIFFERENCES IN THE STANDARDIZATION MATERIALS AND PROCEDURES USED. AN INTERFERING FACTOR CAN MOST LIKELY BE EXCLUDED. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM.