ELECSYS CEA ASSAY
Received Jul 13, 2018 · Event occurred Jun 4, 2018
Report 1823260-2018-02315 · MDR key 7685504
Device
Generic name
Carcinoembryonic Antigen Test System
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04491777190
Lot number
268397
Product problems
- High Test Results
- High Test Results
Patient
62 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE SAMPLE WAS PROVIDED FOR INVESTIGATION. THE CUSTOMER'S RESULT COULD BE REPRODUCED ON A E 601 MODULE. A GENERAL REAGENT ISSUE CAN BE EXCLUDED AND NO PRODUCT PROBLEM WAS FOUND. THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE CUSTOMER COMPLAINED OF DISCREPANT ELECSYS CEA ASSAY RESULTS FOR 1 PATIENT ON A COBAS 8000 E 602 MODULE SERIAL NUMBER (B)(4). THE CEA RESULT WAS 9.52 NG/ML ON THE E 602 MODULE. THE CEA RESULT WAS 1.20 NG/ML ON A BECKMAN INSTRUMENT. THE CEA RESULT WAS 3.63 NG/ML ON AN ABBOTT INSTRUMENT. ON (B)(6) 2018 A NEW SAMPLE WAS COLLECTED FROM THE PATIENT AND THE CEA RESULT WAS 8.81 NG/ML. ON (B)(6) 2018 THE NEW SAMPLE WAS TESTED ON A BECKMAN UNICEL DSL 800 AND THE CEA RESULT WAS 1.48 NG/ML. ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.