ELECSYS FT3 III
Received Mar 31, 2023 · Event occurred Feb 28, 2023
Report 1823260-2023-01025 · MDR key 16657022
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
NACatalog number
09005811190
Lot number
ASKU, 611920, 611918
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
FURTHER INVESTIGATIONS OF THE PATIENT SAMPLE WERE ABLE TO REPRODUCE THE RESULTS OBTAINED AT THE CUSTOMER SITE. IT WAS DETERMINED THE SAMPLE CONTAINED AN INTERFERING FACTOR AGAINST THE FT3 ASSAY ANTIBODY/IDIOTYPE. 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."
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III VER. 2 (FT3 III V 2) AND WITH THE ELECSYS FT4 III ASSAY ON TWO COBAS E 801 MODULES AND A COBAS E 411 IMMUNOASSAY ANALYZER. THE VALUES MEASURED AT THE CUSTOMER SITE WERE REPORTED OUTSIDE OF THE LABORATORY TO A PHYSICIAN. THE SPECIFIC DATE OF THE EVENT IS NOT KNOWN. THE SAMPLE IN QUESTION WAS COLLECTED ON (B)(6) 2023. THIS MEDWATCH WILL APPLY TO THE FT3 III V 2 DATA. PLEASE REFER 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 SAMPLE WAS INITIALLY TESTED TWICE ON THE CUSTOMER'S E 801 ANALYZER ON AN UNKNOWN DATE. THE SAMPLE WAS PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED ON A SECOND E 801 ANALYZER ON (B)(6) 2023 AND ON AN E411 ANALYZER ON (B)(6) 2023. THE SAMPLE WAS ALSO REPEATED ON AN ABBOTT ARCHITECT ANALYZER ON (B)(6) 2023. THE SERIAL NUMBER OF THE CUSTOMER'S E 801 ANALYZER WAS REQUESTED, BUT NOT PROVIDED. THE FT3 III V 2 REAGENT LOT NUMBER AND EXPIRATION DATE USED ON THIS ANALYZER WERE REQUESTED, BUT NOT PROVIDED. THE SERIAL NUMBER OF THE E 801 ANALYZER USED FOR INVESTIGATION IS (B)(4). FT3 III V 2 REAGENT LOT 611920, WITH AN EXPIRATION DATE OF 31-MAY-2023 WAS USED ON THIS ANALYZER. THE SERIAL NUMBER OF THE E411 ANALYZER USED FOR INVESTIGATION WAS (B)(4). FT3 III V 2 REAGENT LOT 611918, WITH AN EXPIRATION DATE OF 30-MAY-2023 WAS USED ON THIS ANALYZER.
Additional Manufacturer Narrative
THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION.