ELECSYS FT3 III
Received Jan 12, 2024 · Event occurred Feb 9, 2023
Report 1823260-2024-00124 · MDR key 18502536
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsCatalog number
09005811190
Lot number
ASKU
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Non Reproducible Results
- Incorrect, Inadequate or Imprecise Result or Readings
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER'S ANALYZER SERIAL NUMBER WAS NOT PROVIDED. THE INVESTIGATIONAL E801 ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATIONAL E411 ANALYZER SERIAL NUMBER IS (B)(6). THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION, THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON TWO COBAS E 801 MODULES AND A COBAS E 411 IMMUNOASSAY ANALYZER. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA.
Additional Manufacturer Narrative
THE PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION. THE INVESTIGATION DID NOT IDENTIFY AN INTERFERING FACTOR IN THE PATIENT SAMPLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.