ELECSYS FT3 III
Received Sep 6, 2023 · Event occurred Aug 17, 2023
Report 1823260-2023-02897 · MDR key 17694934
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsCatalog number
09005803190
Lot number
660556
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
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE ISSUE IS LIKELY RELATED TO FOAM PRESENT ON THE REAGENT AFTER REPLACEMENT OF THE REAGENT KITS.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE E601 ANALYZER IS (B)(6). 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 6000 E601 MODULE. THE ISSUE OCCURRED WHEN STARTING TO USE A NEW REAGENT KIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN FT3 VALUE OF 32.55 PG/ML. THE SAMPLE DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS, SO THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 2.67 PG/ML.