ELECSYS CEA ASSAY
Received Dec 19, 2022 · Event occurred Nov 28, 2022
Report 1823260-2022-04077 · MDR key 16004402
Device
Generic name
System, Test, Carcinoembryonic Antigen
Manufacturer
Roche DiagnosticsModel number
E601Catalog number
04491777160
Lot number
62773601
Product problems
- Low Test Results
- Low Test Results
Patient
57 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THE ISSUE WAS RESOLVED BY THE CUSTOMER RECALIBRATING THE ASSAY.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE CEA ELECSYS RESULT FROM COBAS 6000 E601 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 0.97 NG/ML AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE QC PERFORMED AFTERWARD WAS NOT ACCEPTABLE. THE CUSTOMER RECALIBRATED THE ASSAY AND RAN QC WHICH WAS ACCEPTABLE. THE CUSTOMER THEN REPEATED THE SAMPLE. THE REPEAT RESULT WAS 1.54 NG/ML AND WAS DEEMED CORRECT.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING.