ELECSYS FT4 IV
Received Apr 27, 2026
Report 1823260-2026-01646 · MDR key 25002387
Device
Generic name
Free Thyroxine
Manufacturer
Roche DiagnosticsModel number
FT4 IVCatalog number
09043284190
Lot number
ASKU
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Low Test Results
Patient
NA · Unknown
- 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: SAMPLES FROM THE PATIENT WERE PROVIDED FOR INVESTIGATION. 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 RESULTS FOR TWO SAMPLES COLLECTED FROM ONE PATIENT TESTED WITH ELECSYS FT4 IV ON A COBAS E 801 ANALYTICAL UNIT. 2. PATIENT AGE RANGE: 80 YEARS. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: MALE. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.