ELECSYS FT3 III
Received Apr 27, 2026 · Event occurred Jun 1, 2025
Report 1823260-2026-01628 · MDR key 25001858
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
FT3 IIICatalog number
09005811190
Lot number
ASKU
Product problems
- High Test Results
Patient
71 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE SAMPLES HAVE BEEN REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE TEST RESULTS AND A SUSPECTED INTERFERENCE FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THE AFFECTED ASSAYS ARE ELECSYS FT3 III, ELECSYS FT4, ANTI-TPO, ANTI-TG, AND ANTI-TSHR. PLEASE REFER TO THE HIGHLIGHTED PATIENT RESULTS IN THE ATTACHMENT "(B)(4). IT WAS ALLEGED THAT THE RESULTS DO NOT MATCH THE PATIENT'S CLINICAL PICTURE. THIS MEDWATCH WILL APPLY TO THE ELECSYS FT3 III ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS ANTI-TPO ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS ANTI-TG ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS ANTI-TSHR ASSAY.