ELECSYS CEA
Received May 9, 2025 · Event occurred Apr 16, 2025
Report 1823260-2025-01458 · MDR key 21996643
Device
Generic name
Carcinoembryonic Antigen Test System
Manufacturer
Roche DiagnosticsCatalog number
07027079190
Lot number
80117601
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A GENERAL REAGENT OR ANALYZER PROBLEM CAN BE EXCLUDED BECAUSE THE QC AFTER THE EVENT WAS WITHIN RANGES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE COBAS E801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 4 PATIENTS' SAMPLES TESTED WITH ELECSYS CEA ASSAY ON A COBAS E801 ANALYTICAL UNIT. SAMPLE 1: INITIAL RESULT: <0.3 NG/ML (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 855 NG/ML. SAMPLE 2: INITIAL RESULT: <0.3 NG/ML (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 7.69 NG/ML. SAMPLE 3: INITIAL RESULT: <0.3 NG/ML (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 2.87 NG/ML. SAMPLE 4: INITIAL RESULT: <0.3 NG/ML (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 1.89 NG/ML. THE INITIAL RESULTS WERE LOWER THAN THE TECHNICAL TEST LIMIT, PROMPTING THE REPEAT OF THE SAMPLES. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.