ELECSYS FT4 III
Received Aug 14, 2023 · Event occurred Jul 19, 2023
Report 1823260-2023-02617 · MDR key 17541017
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Roche DiagnosticsCatalog number
07976836190
Lot number
ASKU
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MEDWATCH FIELD D1 BRAND NAME WAS UPDATED.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE CUSTOMER'S COBAS E411 DISK IS (B)(6).BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TSH AND ELECSYS FT4 III RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E411 DISK. THIS MEDWATCH IS FOR THE FT4 III ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE TSH ASSAY. IT IS UNKNOWN IF THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT WAS 0.039 NG/DL WITH A DATA FLAG. THE FIRST REPEAT RESULT WAS 1.18 NG/DL. THE SECOND REPEAT RESULT WAS 1.18NG/DL.