COBAS E-ELECSYS CEA
Received Jan 22, 2015 · Event occurred Jan 5, 2015
Report 1823260-2015-00504 · MDR key 4440270
Device
Generic name
System, Test, Carcinoembryonic Antigen
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04491777160
Lot number
180801
Product problems
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SAMPLE FROM THE PATIENT WAS SENT FOR INVESTIGATION AND THE CUSTOMER'S RESULT COULD BE CONFIRMED. ANALYSIS OF DILUTION LINEARITY OF THE SAMPLE COMBINED WITH INVESTIGATION OF INTERFERENCE TESTING DID NOT SHOW EVIDENCE FOR AN ERRONEOUS RESULT IN THE ELECSYS ASSAY. THE CUSTOMER'S CEA RESULT WAS CONSIDERED TO BE THE CORRECT. THE REAGENT PERFORMED WITHIN SPECIFICATION.
Description of Event or Problem
THE CUSTOMER RECEIVED A QUESTIONABLE CARCINOEMBRYONIC ANTIGEN (CEA) RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT FROM COBAS 6000 E601 ANALYZER SERIAL NUMBER 26C6-25 AT THE CUSTOMER SITE WAS > 1000 NG/ML AND WITH A 1:10 DILUTION WAS 3648 NG/ML. THE SAMPLE WAS SUBMITTED FOR FURTHER INVESTIGATION AND THE RESULT FROM A COBAS E411 ANALYZER WAS >1000 NG/ML AND WITH A 1:10 DILUTION WAS 4475 NG/ML. THE SAMPLE WAS ALSO TESTED ON A LUMIPULSE ANALYZER AND THE RESULT WAS 6680 NG/ML. INFORMATION CONCERNING WHICH RESULT WAS REPORTED OUTSIDE THE LAB AND IF THE PATIENT WAS ADVERSELY AFFECTED WAS REQUESTED BUT WAS NOT PROVIDED.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).