ELECSYS CEA
Received Oct 23, 2025 · Event occurred Sep 28, 2025
Report 1823260-2025-04297 · MDR key 23365420
Device
Generic name
Carcinoembryonic Antigen Test System
Manufacturer
Roche DiagnosticsCatalog number
07027079188
Lot number
84013502
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Non Reproducible Results
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Non Reproducible Results
Patient
39 YR · 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 WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CEA RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 5.84 NG/ML. THIS RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE REPEAT RESULT WAS 1.79 NG/ML AND WAS MORE CONSISTENT WITH THE HISTORICAL RESULTS FOR THE PATIENT. THE QUESTIONED RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY.
Additional Manufacturer Narrative
MEDWATCH FIELDS D4 LOT NO, D4 CATALOG NO, PRIMARY UDI NUMBER, AND G1 WERE UPDATED. A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT PRESENT, BECAUSE THE QC BEFORE THE EVENT WAS WITHIN RANGES. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. NO PRODUCT PROBLEM WAS FOUND.