ELECSYS ANTI-TPO
Received Jun 11, 2026 · Event occurred May 14, 2026
Report 1823260-2026-02314 · MDR key 25476331
Device
Generic name
System, Test, Thyroid Autoantibody
Manufacturer
Roche DiagnosticsCatalog number
06368590190
Lot number
90064801
Product problems
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E 411 ANALYZER (DISK SYSTEM) SERIAL NUMBER IS (B)(6).
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-TPO ASSAY RESULTS FOR 2 PATIENT SAMPLES TESTED ON THE COBAS E 411 ANALYZER (DISK SYSTEM). SAMPLE 1: THE INITIAL RESULT WAS "NEGATIVE". THE REPEAT RESULT AT 1:2 DILUTION WAS 613.4 IU/ML. THE REPEAT RESULT AT AN UNKNOWN DILUTION WAS 411.8 IU/ML. THE REPEAT RESULT AT 1:2 DILUTION WAS 643 IU/ML. THE REPEAT RESULT AT 1:10 DILUTION WAS 1218 IU/ML. THE REPEAT RESULT AT AN UNKNOWN DILUTION WAS 429.6 IU/ML. THE REPEAT RESULT AT 1:5 DILUTION WAS 911.5 IU/ML. SAMPLE 2: THE INITIAL RESULT WAS "NEGATIVE". THE REPEAT RESULT AT 1:2 DILUTION WAS 115.12 IU/ML. THE REPEAT RESULT AT 1:10 DILUTION WAS 133.3 IU/ML. THE REPEAT RESULT AT AN UNKNOWN DILUTION WAS 106.2 IU/ML. THE REPEAT RESULT AT 1:2 DILUTION WAS 120.0 IU/ML. THE REPEAT RESULT AT 1:10 DILUTION WAS 147.8 IU/ML. THE REPEAT RESULT AT AN UNKNOWN DILUTION WAS 106.1 IU/ML. THE REPEAT RESULT AT 1:5 DILUTION WAS 119.6 IU/ML. THE INITIAL RESULT SHOULD HAVE BEEN POSITIVE, PROMPTING THE RERUN. THE REPEAT RESULTS WITH DILUTIONS WERE CONSISTENT WITH THE PATIENT'S HISTORY. THE CUSTOMER SUSPECTS AN INTERFERENT IN THE PATIENT SAMPLE.