ELECSYS T3
Received Jul 24, 2025
Report 1823260-2025-02266 · MDR key 22587467
Device
Generic name
Radioimmunoassay, Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
T3Catalog number
09007733190
Lot number
77885401
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
1. DESCRIBE THE EVENT: THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 1 PATIENT TESTED WITH ELECSYS T3 ON A COBAS E 801 ANALYTICAL UNIT. 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 COULD NOT IDENTIFY A PRODUCT ISSUE. NO INTERFERING FACTOR PRESENT IN THE SAMPLE COULD BE CONFIRMED. SAMPLE VOLUME WAS NOT SUFFICIENT FOR FURTHER INVESTIGATIONS. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. 3. DEVICE RETURNED TO MANUFACTURER? NO 4. DEVICE LABELED "FOR SINGLE USE?" NO 5. DEVICE REPROCESSED AND REUSED? NO