CARCINOEMBRYONIC ANTIGEN - CEA
Received Dec 28, 2015 · Event occurred Dec 4, 2015
Report 1823260-2015-06122 · MDR key 5329085
Device
Generic name
System, Test, Carcinoembryonic Antigen
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11731629322
Lot number
185168
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR CARCINOEMBRYONIC ANTIGEN (CEA). THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL CEA RESULT WAS 600 NG/ML. THE SAMPLE WAS DILUTED MANUALLY X10 AND AUTOMATICALLY DILUTED X400 AND THE RESULT WAS 510,000 NG/ML. BOTH RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. IT WAS NOTED THAT THE HIGH RESULTS FOR CEA MATCH THE PHYSICAL CONDITION OF THE PATIENT. NO ADVERSE EVENT OCCURRED. THE E602 ANALYZER SERIAL NUMBER WAS NOT PROVIDED.
Additional Manufacturer Narrative
THE SAMPLE WAS SUBMITTED FOR INVESTIGATION. THE CUSTOMER'S VALUES WERE REPRODUCIBLE. THE MOST LIKELY ROOT CAUSE IS DUE TO A HIGH DOSE HOOK EFFECT DUE TO THE HIGH CEA CONCENTRATION IN THE SAMPLE. THE CEA CONCENTRATION IS ABOVE THE HIGH DOSE HOOK CONCENTRATION OF 200,000 NG/ML.