ELECSYS FT3 III
Received Oct 4, 2023 · Event occurred Sep 4, 2023
Report 1823260-2023-03179 · MDR key 17869811
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
09005811190Catalog number
09005811190
Lot number
669112
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER'S E801 ANALYZER SERIAL NUMBER IS (B)(6). THE CUSTOMER'S FT3 REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE INVESTIGATIONAL E801 ANALYZER SERIAL NUMBER IS (B)(6). THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON TWO COBAS E 801 MODULES. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA.
Additional Manufacturer Narrative
**UDI RELATED DATA QUALITY UPDATES ONLY** D3 IS THE INITIAL DISTRIBUTOR IN THE US.
Additional Manufacturer Narrative
THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE CUSTOMER'S FT3 RESULTS COULD NOT BE REPRODUCED. THE INVESTIGATION CONFIRMED THE PRESENCE OF AN INTERFERING FACTOR AGAINST THE IDIOTYPE OF THE MONOCLONAL ANTIBODY OF THE FT3 ASSAY. 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." NO PRODUCT PROBLEM WAS IDENTIFIED.