ACCESS CEA
Received Aug 18, 2014 · Event occurred Jul 11, 2014
Report 2122870-2014-00587 · MDR key 4014364
Device
Generic name
System, Test, Carcinoembryonic Antigen
Manufacturer
Beckman CoulterModel number
NACatalog number
33200
Lot number
495090
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THERE IS NO INDICATION THAT THE ACCESS GI MONITOR DEVICE WAS RETURNED FOR EVALUATION. SERVICE WAS NOT DISPATCHED AS THE CUSTOMER DID NOT QUESTION SYSTEM PERFORMANCE. IN CONCLUSION, A DEFINITIVE CAUSE OF THE INCIDENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. (B)(6). THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2014-00575.
Description of Event or Problem
THE CUSTOMER REPORTED NON-REPRODUCIBLE CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS, FOR ONE PATIENT, INVOLVING THE ACCESS CEA ASSAY USED IN CONJUNCTION WITH THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THIS REPORT IS TWO OF TWO REFERENCING THE MEDICAL DEVICE NOTED. THE CUSTOMER STATED THE INITIAL RESULT WAS LOWER THAN EXPECTED AND DID NOT CORRELATE WITH THE PATIENT'S CLINICAL STATUS. A SECOND SAMPLE, FROM THE PATIENT, TESTED ON THE SAME INSTRUMENT, GENERATED A HIGHER VALUE WHICH WAS WITHIN EXPECTATIONS AND CORRELATED WITH THE PATIENT'S CLINICAL HISTORY. THE INITIAL RESULT WAS RELEASED OUT OF THE LABORATORY, AND AN AMENDED REPORT (RESULTS FROM THE SECOND SAMPLE) WAS ISSUED TO THE HOSPITAL. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER STATED QUALITY CONTROL (QC) WAS WITHIN SPECIFICATION AND THERE WERE NO SYSTEM ISSUES. THE INSTRUMENT WAS IN NORMAL OPERATION.