ELECSYS CEA
Received Jan 8, 2025 · Event occurred Dec 17, 2024
Report 1823260-2025-00053 · MDR key 21104969
Device
Generic name
Carcinoembryonic Antigen Test System
Manufacturer
Roche DiagnosticsCatalog number
04491777190
Lot number
791246
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
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH ELECSYS CEA ON A COBAS 8000 E 602 MODULE. THE CUSTOMER PROVIDED EXAMPLES OF 15 PATIENT SAMPLES WITH DISCREPANT CEA RESULTS. THE CUSTOMER NOTICED MULTIPLE CONSECUTIVE HIGH RESULTS. AFTER RECEIVING A CLINICAL COMPLAINT ON 20-DEC-2024, THE SAMPLES WERE REPEATED AND THE RESULTS WERE WITHIN THE ASSAY REFERENCE RANGE. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE E 602 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
A GENERAL REAGENT ISSUE CAN BE EXCLUDED AS CONTROLS RUN PRIOR TO THE EVENT WERE WITHIN RANGE. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.