ELECSYS T3
Received Jun 7, 2023 · Event occurred May 15, 2023
Report 1823260-2023-01894 · MDR key 17081399
Device
Generic name
Radioimmunoassay, Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
NACatalog number
ASKU
Lot number
ASKU
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
SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION AND A STREPTAVIDIN INTERFERING FACTOR WAS FOUND. PRODUCT LABELING DOCUMENTS THIS INTERFERENCE: 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. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS. A GENERAL PRODUCT PROBLEM COULD BE EXCLUDED.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS FOR ONE PATIENT FROM COBAS 8000 E 801 SERIAL NUMBER (B)(6) DUE TO INTERFERENCE. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON AN ABBOTT ANALYZER AND THE RESULTS WERE NORMAL AND IN LINE WITH THE CLINICAL EXPECTATIONS. THIS MEDWATCH IS FOR THE T3 ASSAY. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING.