ELECSYS T4
Received Jul 24, 2025
Report 1823260-2025-02269 · MDR key 22587462
Device
Generic name
Total Thyroxine Assay
Manufacturer
Roche DiagnosticsModel number
T4Catalog number
09007741190
Lot number
805868
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- Low Readings
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- Low 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: 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 ABOUT QUESTIONABLE HIGH RESULTS FOR 1 PATIENT TESTED FOR ELECSYS T4 ON A COBAS 6000 E601 MODULE. 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 DETERMINED THAT THE ISSUE WAS RELATED TO MAINTENANCE. THE CAUSE OF THE EVENT WAS DUE TO FAILING PINCH VALVES, A BENT REAGENT PROBE, AND A LOW VOLTAGE ON THE PROBE (COMPONENT FAILURE). 2. SUMMARY OF FOLLOW-UP/CORRECTIVE ACTIONS TAKEN: THE FIELD SERVICE ENGINEER REPLACED THE PINCH VALVES, THE REAGENT AND THE SAMPLE PROBES.