ELECSYS T4
Received Feb 28, 2024 · Event occurred Feb 7, 2024
Report 1823260-2024-00582 · MDR key 18801756
Device
Generic name
Radioimmunoassay, Total Thyroxine
Manufacturer
Roche DiagnosticsCatalog number
09007784190
Lot number
741920
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Non Reproducible Results
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6) . THE CALIBRATION AND QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T4 ASSAY RESULTS FOR 3 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER QUESTIONED THE HIGH INITIAL RESULTS WHICH PROMPTED THEM TO REPEAT THE SAMPLES. FOR SAMPLE 1, THE INITIAL T4 RESULT WAS 24.9 UG/DL WITH FLAG. THE SAMPLE WAS REPEATED AND THE REPEAT RESULT WAS 13.9 UG/DL. THE SAMPLE WAS REPEATED A THIRD TIME THE NEXT DAY AND THE RESULT WAS 8.56 UG/DL. FOR SAMPLE 2, THE INITIAL T4 RESULT WAS 24.9 UG/DL WITH FLAG. THE SAMPLE WAS REPEATED THE NEXT DAY AND THE REPEAT RESULT WAS 8.47 UG/DL. FOR SAMPLE 3, THE INITIAL T4 RESULT WAS 24.9 UG/DL WITH FLAG. THE SAMPLE WAS REPEATED AND THE REPEAT RESULT WAS 8.60 UG/DL. THE SAMPLE WAS REPEATED A THIRD TIME THE NEXT DAY AND THE RESULT WAS 8.63 UG/DL.