ELECSYS FT4 IV
Received Apr 27, 2026
Report 1823260-2026-01655 · MDR key 25002382
Device
Generic name
Free Thyroxine
Manufacturer
Roche DiagnosticsModel number
FT4 IVCatalog number
09043284214
Lot number
ASKU,88888401
Product problems
- High Test Results
- Low Test Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
1. THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT4 IV RESULTS FOR: ONE PATIENT FROM THE COBAS 8000 CORE UNIT. ONE PATIENT ON A COBAS E 402 ANALYTICAL UNIT COMPARED TO THE ABBOTT METHOD. TWO PATIENTS FROM THE COBAS E 801 MODULE. ONE PATIENT ON A COBAS 8000 CORE UNIT COMPARED TO COMPETITOR METHODS. ONE PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A SIEMENS ANALYZER. 2. PATIENT AGE RANGE: 10-83 YEARS. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: 2-FEMALE, 2-MALE, 2-ASKU. 5. PATIENT RACE BREAKDOWN: 5-ASKU, 1-ASIAN. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.
Additional Manufacturer Narrative
FOR FOUR EVENTS: 1. SUMMARY OF INVESTIGATION RESULTS: SAMPLE MATERIAL FROM THE PATIENT WAS REQUESTED FOR INVESTIGATION. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE INVESTIGATION IS ONGOING. FOR ONE EVENT: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: THE INVESTIGATION IS ONGOING. FOR ONE EVENT: 1. SUMMARY OF INVESTIGATION RESULTS: THE INVESTIGATION IS ONGOING. 2. SUMMARY OF FOLLOW UP/CORRECTIVE ACTIONS TAKEN: AN INTERFERENCE IS SUSPECTED IN THE PATIENT SAMPLE. THE SAMPLE WAS REQUESTED FOR INVESTIGATION. FOR ALL 6 EVENT: 3. DEVICE RETURNED TO MANUFACTURER? NO. 4. DEVICE LABELED "FOR SINGLE USE?" NO. 5. DEVICE REPROCESSED AND REUSED? NO. REAGENT LOT 88888401 HAD AN EXPIRATION DATE OF 31-AUG-2026.