ELECSYS T3
Received Dec 15, 2023 · Event occurred Nov 18, 2023
Report 1823260-2023-04034 · MDR key 18335905
Device
Generic name
Radioimmunoassay, Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
09007733190Catalog number
09007733190
Lot number
70412901
Product problems
- False Positive Result
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO PATIENT SAMPLE WAS AVAILABLE FOR INVESTIGATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T3, ELECSYS T4 ASSAY, ELECSYS FT3 III, ELECSYS FT4 III ASSAY, ELECSYS ANTI-TPO, AND ELECSYS ANTI-TG RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 MODULE COMPARED TO AN ABBOTT ANALYZER. THIS MEDWATCH WILL COVER T3. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T4 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 III RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ANTI-TPO RESULTS, AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ANTI-TG RESULTS. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
**UDI RELATED DATA QUALITY UPDATES ONLY** D3 IS THE INITIAL DISTRIBUTOR IN THE US.