ELECSYS FT3 III
Received Apr 3, 2023 · Event occurred Feb 25, 2023
Report 1823260-2023-01064 · MDR key 16666007
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
NACatalog number
09005811190
Lot number
611920, 611918
Product problems
- High Test Results
- High Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER SUSPECTS AN INTERFERING SUBSTANCE IN THE PATIENT'S SAMPLE. THERE WAS NOT ENOUGH PATIENT SAMPLE VOLUME REMAINING TO PERFORM INTERFERENCE TESTING. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THERE WAS AN ALLEGATION OF DISCREPANT ELECSYS FT3 III VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 CORE UNIT COMPARED TO A COBAS E 411 IMMUNOASSAY ANALYZER, A WAKO ACCURASEED ANALYZER, AND AN ABBOTT ARCHITECT ANALYZER. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER'S ANALYZER SERIAL NUMBER IS (B)(6). THE CUSTOMER'S FT3 REAGENT LOT AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED. THE INVESTIGATIONAL E801 ANALYZER SERIAL NUMBER IS (B)(6). THE FT3 REAGENT LOT USED IS 611920. THE INVESTIGATIONAL E411 ANALYZER SERIAL NUMBER IS (B)(6). THE FT3 REAGENT LOT USED IS 611918 AND THE EXPIRATION DATE IS 30-MAY-2023.