ELECSYS TG II
Received Aug 26, 2025 · Event occurred Jul 30, 2025
Report 1823260-2025-02609 · MDR key 22893182
Device
Generic name
Thyroglobulin Test System
Manufacturer
Roche DiagnosticsCatalog number
08906564190
Lot number
85444701
Product problems
- High Test Results
- Non Reproducible Results
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TG II RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. ONE EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED: THE INITIAL RESULT FROM THE ANALYZER WAS 0.136 NG/ML WITH A DATA FLAG. THE FIRST REPEAT RESULT FROM THE ANALYZER WAS 0.347 NG/ML. THE DOCTOR DEEMED THE RESULT TOO HIGH FOR THE PATIENT. THE SECOND REPEAT RESULT FROM ANOTHER ROCHE ANALYZER WAS < 0.0400 NG/ML WITH A DATA FLAG. THIS RESULT WAS DEEMED CORRECT.
Additional Manufacturer Narrative
THE INVESTIGATION INCLUDED A REVIEW OF THE DATA SET PROVIDED BY THE CUSTOMER: THE CALIBRATION AND QC RESULTS WERE WITHIN THE SPECIFIED RANGES. THE ALARM TRACE DID NOT INDICATE ANY ISSUES. A GENERAL REAGENT PROBLEM WAS NOT DETECTED BECAUSE THE QC BEFORE THE EVENT WAS WITHIN RANGES, AND NON-SYSTEMATIC AND NON-REPRODUCIBLE RESULTS DO NOT REPRESENT A GENERAL MALFUNCTION OF THE ASSAY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.