ELECSYS CEA
Received Oct 21, 2024 · Event occurred Sep 25, 2024
Report 1823260-2024-03031 · MDR key 20494941
Device
Generic name
Carcinoembryonic Antigen Test System
Manufacturer
Roche DiagnosticsCatalog number
07027079190
Lot number
801176
Product problems
- High Test Results
- Non Reproducible Results
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CALIBRATION WAS LAST PERFORMED ON 12-SEP-2024 WITH ACCEPTABLE RESULTS. QC WAS ACCEPTABLE BEFORE THE EVENT. FOUR "SAMPLE CLOT DETECTION" AND ONE "SAMPLE FOAM DETECTION" ALARM WERE OBSERVED ON THE ALARM TRACE DATA FROM (B)(6) 2024. DURING A REVIEW OF THE SAMPLE FOAM DETECTION IMAGES, DIRT WAS OBSERVED ON THE GRIPPER. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Additional Manufacturer Narrative
THE E801 MODULE SERIAL NUMBER IS (B)(6).
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CEA (CEA) ON A COBAS E 801 MSB/MSBL. THE INITIAL RESULT WAS 11.8 NG/L. THE REPEAT RESULT WAS <0.3 NG/L. ON (B)(6) 2025 THE REPEAT RESULT WAS <0.3 NG/L. THE INITIAL RESULT DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL CONDITION AND THE SAMPLE WAS REPEATED. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.