ELECSYS CEA
Received Jun 23, 2023 · Event occurred May 26, 2023
Report 1823260-2023-02073 · MDR key 17194733
Device
Generic name
System, Test, Carcinoembryonic Antigen
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11731629322
Lot number
627730
Product problems
- Incorrect Measurement
- Incorrect Measurement
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO SAMPLE MATERIAL WAS SUBMITTED FOR INVESTIGATION. BASED ON THE AVAILABLE DATA, THE INVESTIGATION FOUND THE MOST LIKELY CAUSE WAS PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM A COBAS E411 RACK ANALYZER. PATIENT 1 INITIAL CEA ELECSYS RESULT WAS > 1000 NG/ML. THE REPEAT RESULT WITH A 1:50 AUTOMATIC DILUTION WAS < 10 NG/ML. THE REPEAT RESULT WITH A 1:50 AUTOMATIC DILUTION WAS 2895 NG/ML. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2023, PATIENT 2 INITIAL TOTAL PSA RESULT WAS >100.0NG/ML AND THE RESULT WITH A 1:50 AUTOMATIC DILUTION (1:50) WAS 0.023 NG/ML. INFORMATION WAS NOT PROVIDED IF THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABOROARY.
Additional Manufacturer Narrative
THE ADJUSTMENTS OF THE SAMPLE/REAGENT SIPPER AND THE CALIBRATION WERE CHECKED. QUALITY CONTROL WAS ACCEPTABLE. THE COBAS E411 RACK ANALYZER SERIAL NUMBER WAS (B)(6).. THE INVESTIGATION IS ONGOING.