ELECSYS CEA
Received Jun 16, 2025 · Event occurred May 26, 2025
Report 1823260-2025-01844 · MDR key 22210556
Device
Generic name
System, Test, Carcinoembryonic Antigen
Manufacturer
Roche DiagnosticsCatalog number
11731629322
Lot number
79121601
Product problems
- Low Test Results
- Pumping Problem
- Non Reproducible Results
- Low Test Results
- Pumping Problem
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CEA RESULTS FROM THE COBAS 8000: COBAS E 602 MODULE. SAMPLE 1 INITIAL RESULT WAS 0.2 NG/ML WITH A DATA FLAG, AND THE REPEAT RESULT WAS 81.2 NG/ML. SAMPLE 2 INITIAL RESULT WAS 0.2 NG/ML WITH A DATA FLAG, AND THE REPEAT RESULT WAS 116.6 NG/ML. SAMPLE 3 INITIAL RESULT WAS 0.2 NG/ML WITH A DATA FLAG, AND THE REPEAT RESULT WAS 8.17 NG/ML. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE COBAS 8000: COBAS E 602 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
DUE TO THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THERE WAS NO PRODUCT PROBLEM IDENTIFIED. A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT PRESENT, BECAUSE THE QC PRIOR TO THE EVENT WAS WITHIN RANGES.