ELECSYS FT3 III
Received Jul 19, 2023 · Event occurred May 20, 2023
Report 1823260-2023-02359 · MDR key 17356789
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
NACatalog number
09005811190
Lot number
669112, 686656
Product problems
- High Test Results
- High Test Results
Patient
60 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT ON TWO COBAS E 801 MODULES AND A COBAS E 411 IMMUNOASSAY ANALYZER COMPARED TO A WAKO ACCURASEED ANALYZER. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE CUSTOMER'S ANALYZER SERIAL NUMBER, REAGENT LOT NUMBER, AND EXPIRATION DATE WERE NOT PROVIDED. THE INVESTIGATIONAL E801 ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATIONAL E411 ANALYZER SERIAL NUMBER IS (B)(6). THE REAGENT LOT NUMBER USED WAS 686656 WITH AN EXPIRATION DATE OF 30-APR-2024. THE SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION. THE INVESTIGATION DETERMINED THAT THERE IS AN INTERFERING FACTOR AGAINST THE IDIOTYPE OF THE MONOCLONAL ANTIBODY OF THE FT3 ASSAY IN THE SAMPLE. 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 ISSUE WAS IDENTIFIED.