T4 ELECSYS E2G 300 V2
Received Feb 21, 2022 · Event occurred Jan 29, 2022
Report 1823260-2022-00467 · MDR key 13569155
Device
Generic name
Total Thyroxine Assay
Manufacturer
Roche DiagnosticsModel number
NACatalog number
09007741190
Lot number
53112600
Product problems
- Display or Visual Feedback Problem
- Non Reproducible Results
- Display or Visual Feedback Problem
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. NA.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED A QUESTIONABLE T4 ELECSYS E2G 300 V2 RESULT FOR ONE PATIENT SAMPLE TESTED ON A COBAS E411 RACK WITH SERIAL NUMBER: (B)(4) COMPARED TO A VIDAS ANALYZER. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE RESULT FROM THE E 411 AT 1:51 PM WAS 246.5 NMOL/L WITH A DATA FLAG. THE RESULT FROM THE VIDAS ANALYZER AT 2:00 PM WAS 130.96 NMOL/L. THE VIDAS RESULT WAS REPORTEDLY MORE CONSISTENT WITH THE TOTAL THYROID PROFILE OF THE PATIENT.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. NA.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED A QUESTIONABLE T4 ELECSYS E2G 300 V2 RESULT FOR ONE PATIENT SAMPLE TESTED ON A COBAS E411 RACK WITH SERIAL NUMBER: (B)(4) COMPARED TO A VIDAS ANALYZER. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE RESULT FROM THE E 411 AT 1:51 PM WAS 246.5 NMOL/L WITH A DATA FLAG. THE RESULT FROM THE VIDAS ANALYZER AT 2:00 PM WAS 130.96 NMOL/L. THE VIDAS RESULT WAS REPORTEDLY MORE CONSISTENT WITH THE TOTAL THYROID PROFILE OF THE PATIENT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE CAUSE OF THE EVENT COULD NOT BE DERTERMINED.