MalfunctionNIG
ELECSYS CA 19-9
Received Jul 1, 2026 · Event occurred Jun 7, 2026
Report 1823260-2026-02629 · MDR key 25676845
Device
Generic name
Carbohydrate Antigen (ca19-9) Test System
Manufacturer
Roche DiagnosticsCatalog number
07027028190
Lot number
84908301
Product problems
- High Test Results
- Low Test Results
- Non Reproducible Results
Patient
28 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 86.1 U/ML, AND THE REPEATED RESULT WAS 7.94 U/ML. THE SAMPLE WAS REPEATED ON ANOTHER MODULE, AND THE RESULT WAS 7.94 U/ML. THE SAMPLE WAS REPEATED BECAUSE THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS.
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.