ELECSYS FT3 III
Received Jan 24, 2025
Report 1823260-2025-00230 · MDR key 21232801
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
FT3 IIICatalog number
09005803190
Lot number
ASKU
Product problems
- High Test Results
- Non Reproducible Results
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SUMMARY OF INVESTIGATION RESULTS: DUE TO THE LIMITED INFORMATION ABOUT THE ISSUE, NO CLEAR ROOT CAUSE COULD BE FOUND. THE PROVIDED DATA DO NOT INDICATE A REAGENT ISSUE. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: NO FOLLOW UP/CORRECTIVE ACTIONS WERE TAKEN.
Description of Event or Problem
1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR ONE PATIENT FROM THE COBAS 6000 E601 MODULE. 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 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.