ELECSYS FT3 III
Received Dec 28, 2023 · Event occurred Dec 2, 2023
Report 1823260-2023-04197 · MDR key 18411544
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
09005811190Catalog number
09005811190
Lot number
73731401
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 SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(6). THE COMPETITOR METHOD IS ABBOTT. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III ON A COBAS E 801 MODULE. THE SAMPLE RESULTED IN A FT3 VALUE OF 8.41 PG/ML (REFERENCE RANGE = 2.0 - 4.4 PG/ML) WHEN TESTED ON THE E 801 MODULE. THE SAMPLE WAS REPEATED USING A COMPETITOR METHOD, RESULTING IN A FT3 VALUE OF 3.18 PG/ML (REFERENCE RANGE = 1.58 - 3.91 PG/ML).
Additional Manufacturer Narrative
**UDI RELATED DATA QUALITY UPDATES ONLY** D3 IS THE INITIAL DISTRIBUTOR IN THE US.
Additional Manufacturer Narrative
CALIBRATION AND CONTROLS WERE ACCEPTABLE. A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. INVESTIGATIONS OF THE SAMPLE DETERMINED THAT IT CONTAINS AN INTERFERING FACTOR AGAINST THE STREPTAVIDIN COMPONENT OF THE FT3 ASSAY. THIS LIMITATION IS COVERED IN PRODUCT LABELING. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM.