ELECSYS FT3 III
Received Apr 29, 2024
Report 1823260-2024-01307 · MDR key 19203011
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
FT3 IIICatalog number
09005811190
Lot number
73731403
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: 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.
Description of Event or Problem
1. DESCRIBE THE EVENT: THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH ELECSYS FT3 III RESULTS FOR 2 PATIENT SAMPLES. 2. PATIENT AGE RANGE: 1 PATIENT: 86 YEARS, OTHER: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: 1 F, 1 ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.
Additional Manufacturer Narrative
SUMMARY OF INVESTIGATION RESULTS: NO INTERFERING FACTORS WERE IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: ONE PATIENT SAMPLE WAS SUBMITTED FOR INVESTIGATION. DEVICE RETURNED TO MANUFACTURER? NO DEVICES WERE RETURNED. DEVICE LABELED "FOR SINGLE USE"? THIS DEVICE IS NOT LABELED FOR SINGLE USE. DEVICE REPROCESSED AND REUSED? THIS DEVICE IS NOT REPROCESSED OR REUSED.