ELECSYS CA 19-9
Received Dec 22, 2025 · Event occurred Dec 3, 2025
Report 1823260-2025-05280 · MDR key 23865979
Device
Generic name
Carbohydrate Antigen (ca19-9) Test System
Manufacturer
Roche DiagnosticsCatalog number
07027028190
Lot number
849083
Product problems
- High Test Results
- Non Reproducible Results
- High Test Results
- Non Reproducible Results
Patient
74 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CALIBRATION WAS ACCEPTABLE. A GENERAL PRODUCT PROBLEM WAS EXCLUDED. A SAMPLE CLOT ALARM WAS DETECTED TWICE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 E 801 MODULE. THE INITIAL RESULT IS 69.1 U/ML. THE REPEATED RESULT IS 3.99 U/ML (REPORTED AS 4.0 U/ML). THIS RESULT WAS CONSISTENT WITH THE PATIENT'S CLINICAL HISTORY.
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (B)(6). TWO OF THE QC LEVELS (1 AND 3) WERE ACCEPTABLE, BUT ONE OF THE LEVELS (LEVEL 2) WAS NOT TESTED. THE INVESTIGATION IS ONGOING.