ELECSYS CA 19-9
Received Apr 21, 2026 · Event occurred Mar 29, 2026
Report 1823260-2026-01530 · MDR key 24944269
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
07027028188
Lot number
86153800
Product problems
- High Test Results
- Non Reproducible Results
Patient
65 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE QC WAS ACCEPTABLE. A GENERAL PRODUCT ISSUE WAS EXCLUDED. THE RELEVANT BATCH RECORDS WERE REVIEWED, AND NO ABNORMALITIES WERE FOUND. THE INVESTIGATION FOUND THE GRIPPER WAS DIRTY. THE INVESTIGATION DETERMINED THE ISSUE WAS DUE TO PRE-ANALYTICAL HANDLING ISSUES.
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 67.1 U/ML. THE REPEATED RESULTS WERE 27.9 U/ML AND 28 U/ML. THE RESULT OF 27.9 U/ML WAS REPORTED. THE SAMPLE WAS REPEATED BECAUSE THE INITIAL RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS.
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.