COBAS E411 RACK SYSTEM
Received Jun 9, 2014 · Event occurred May 22, 2014
Report 1823260-2014-04166 · MDR key 3856120
Device
Generic name
Immunochemistry Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04775201001
Lot number
NA
Product problems
- High Test Results
Patient
067 YR
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
NO ROOT CAUSE COULD BE DETERMINED. THE FIELD SERVICE REPRESENTATIVE FOUND THAT THE PERFORMANCE TESTING RESULTS WERE WITHIN RANGE, BUT THE MEASURING CELL CARRYOVER WAS HIGH. THE MEASURING CELL WAS REPLACED AND THE HIGH VOLTAGE WAS ADJUSTED. ANOTHER PERFORMANCE TEST WAS DONE WITH RESULTS WITHIN RANGE. THE INSTRUMENT WAS WORKING WITHIN SPECIFICATION.
Description of Event or Problem
THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE CARCINOEMBRYONIC ANTIGEN (CEA) RESULT FOR ONE PATIENT ON THEIR E411 ANALYZER. THE PATIENT'S INITIAL CEA RESULT WAS 7.6 NG/ML AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED ON AN ADVIA CENTAUR IN ANOTHER LABORATORY, AND THE RESULT WAS 1.4 NG/ML. THERE WERE NO ADVERSE EVENTS. THE CEA REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).