ELECSYS CEA
Received May 9, 2025 · Event occurred Apr 29, 2025
Report 1823260-2025-01450 · MDR key 21994407
Device
Generic name
Carcinoembryonic Antigen Test System
Manufacturer
Roche DiagnosticsCatalog number
07027079190
Lot number
7871700
Product problems
- High Readings
- Low Readings
- High Readings
- Low Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(6). THE CALIBRATION SIGNALS WERE LOW, BUT WITHIN EXPECTATIONS. QUALITY CONTROLS RUN BETWEEN 27-APR-2025 AND 30-APR-2025 WERE WITHIN RANGE. A GENERAL REAGENT ISSUE CAN BE EXCLUDED BECAUSE ANOTHER REAGENT KIT OF THE SAME LOT PERFORMED ACCORDING TO EXPECTATIONS. THE INVESTIGATION IDENTIFIED THE ISSUE WAS RELATED TO THE FAILURE OF A SINGLE REAGENT PACK. THE ROOT CAUSE OF THE FAILURE COULD NOT BE DETERMINED, BUT THE ISSUE IS CONSISTENT WITH TRANSPORT OR STORAGE ISSUES.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 11 PATIENT SAMPLES TESTED WITH ELECSYS CEA ON A COBAS E 801 ANALYTICAL UNIT. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE CUSTOMER STATED THEY OBTAINED SYSTEMATICALLY LOWER RESULTS WITH ONE REAGENT PACK (PACK B) IN COMPARISON TO RESULTS FROM OTHER PACKS OF THE SAME LOT (PACKS A, C, D) AND RESULTS OBTAINED FROM A DIFFERENT LOT ON A SECOND ANALYZER (E602) AT ANOTHER SITE.