ELECSYS T4
Received Oct 23, 2025
Report 1823260-2025-04314 · MDR key 23369188
Device
Generic name
Radioimmunoassay, Total Thyroxine
Manufacturer
Roche DiagnosticsModel number
T4Catalog number
09007784190
Lot number
ASKU
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
1. SUMMARY OF INVESTIGATION RESULTS: SAMPLE MATERIAL FROM THE PATIENT WAS TESTED, AND NO INTERFERING FACTORS WERE DETECTED. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: NONE.
Additional Manufacturer Narrative
1. SUMMARY OF INVESTIGATION RESULTS: SAMPLE MATERIAL FROM THE PATIENT WAS REQUESTED FOR FURTHER INVESTIGATION. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: INVESTIGATION IS ONGOING. 3. DEVICE RETURNED TO MANUFACTURER? NO. 4. DEVICE LABELED "FOR SINGLE USE?" NO. 5. DEVICE REPROCESSED AND REUSED? NO.
Description of Event or Problem
1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T4 RESULTS FOR ONE PATIENT FROM THE COBAS 6000 E601 MODULE. 2. PATIENT AGE RANGE: 53 YEAR. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: MALE. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.