ELECSYS FT3 III
Received Jan 12, 2024 · Event occurred Dec 18, 2023
Report 1823260-2024-00132 · MDR key 18507429
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsCatalog number
09005803190
Lot number
ASKU
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CALIBRATION WAS OVERDUE AND THE SLIGHTLY HIGHER RECOVERY WAS ALSO INDICATED BY THE RISING QC RESULTS. A NEW CALIBRATION WAS PERFORMED, WHICH SOLVED THE ISSUE. A GENERAL PRODUCT PROBLEM CAN BE EXCLUDED.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE CUSTOMER PERFORMED CALIBRATION APPROXIMATELY ONCE PER MONTH.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E411 MODULE. THE INITIAL RESULT WAS 4.5 PG/ML. THE SAMPLE WAS RETESTED, BUT THE RESULT DID NOT CHANGE. THE CUSTOMER PERFORMED CALIBRATION AND REPEATED THE SAMPLE. THE REPEATED RESULT, AFTER CALIBRATION, WAS 3.6 PG/ML.