ELECSYS T3
Received Jul 30, 2024
Report 1823260-2024-02208 · MDR key 19865793
Device
Generic name
Radioimmunoassay, Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
T3Catalog number
ASKU
Lot number
ASKU
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
1. SUMMARY OF INVESTIGATION RESULTS: SINCE THE SAMPLE WAS NOT PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE SAMPLE WAS REQUESTED FOR INVESTIGATION BUT COULD NOT BE PROVIDED. 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. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS T3 COMPARED TO A COMPETITOR METHOD. 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.