ELECSYS T4
Received Jan 30, 2025
Report 1823260-2025-00289 · MDR key 21275399
Device
Generic name
Total Thyroxine Assay
Manufacturer
Roche DiagnosticsModel number
T4Catalog number
09007741190
Lot number
805868
Product problems
- Low Test Results
- Chemical Problem
- Low Test Results
- Chemical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T4 RESULTS FOR 1 PATIENT FROM THE COBAS E411 DISK ANALYZER. 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.
Additional Manufacturer Narrative
1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. FROM THE INFORMATION PROVIDED, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE DIFFERENCES GENERATED BETWEEN THE DIFFERENT METHODS MOST LIKELY RELATE TO NORMAL METHODOLOGICAL DIFFERENCES. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: NO FOLLOW UP/CORRECTIVE ACTIONS WERE TAKEN.