ELECSYS FT3 III
Received Apr 27, 2026
Report 1823260-2026-01644 · MDR key 25002176
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
FT3 IIICatalog number
09005811190
Lot number
88587400
Product problems
- Incorrect Measurement
- High Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
1. DESCRIBE THE EVENT. THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS FT3 III RESULT FROM THE COBAS 8000 E 801 MODULE FOR ONE PATIENT. 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.
Additional Manufacturer Narrative
1. SUMMARY OF INVESTIGATION RESULTS: THE SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE INVESTIGATION IS ONGOING. 3. DEVICE RETURNED TO MANUFACTURER? NO 4. DEVICE LABELED "FOR SINGLE USE?" NO 5. DEVICE REPROCESSED AND REUSED? NO.