CEA ELECSYS
Received Mar 28, 2017 · Event occurred Mar 1, 2017
Report 1823260-2017-00655 · MDR key 6439977
Device
Generic name
System, Test, Carcinoembryonic Antigen
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11731629322
Lot number
ASKU
Product problems
- Low Test Results
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). (B)(6).
Description of Event or Problem
THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT USING THE ELECSYS CEA ASSAY ON AN UNSPECIFIED COBAS ELECSYS SYSTEM. THE CUSTOMER INQUIRED ABOUT PUBLISHED LITERATURE THAT DESCRIBED THE DIFFERENCE BETWEEN A TRUE ZERO RESULT AND A FALSE ZERO RESULT IN IMMUNOLOGY TESTING. THE CUSTOMER THEN PROVIDED RESULTS. THE INITIAL RESULT WAS <0.2 NG/ML. THE REPEAT RESULT WAS 70 NG/ML WHICH WAS CONSIDERED CORRECT. IT IS UNKNOWN WHETHER THESE RESULTS WERE REPORTED TO MEDICAL PERSONNEL. THE CUSTOMER WOULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT WITH THE PATIENT. THE ELECSYS ANALYZER INFORMATION WAS NOT PROVIDED. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. POSSIBLE ROOT CAUSES FOR THIS EVENT MAY BE SAMPLE QUALITY AND INSUFFICIENT MAINTENANCE.