ELECSYS CEA

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S COBAS E 801 ANALYTICAL UNIT IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CEA ASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT FROM THE ANALYZER WAS 4.22 NG/ML (POSITIVE). THE REPEAT RESULT OF THE RECENTRIFUGED PATIENT SAMPLE FROM THE ANALYZER WAS 4.26 NG/ML (POSITIVE). THE PATIENT SAMPLE WAS SENT TO ANOTHER LABORATORY. THE REPEAT RESULT FROM A SIEMENS ANALYZER (CHEMILUMINESCENCE LABORATORY METHOD) WAS 1.58 NG/ML (NEGATIVE). THE REPEAT RESULT FROM A BECKMAN ANALYZER (UNKNOWN LABORATORY METHOD) WAS ALSO NEGATIVE.

Additional Manufacturer Narrative

THE INVESTIGATION REVIEWED THE CALIBRATION AND QC DATA; THE RESULTS WERE WITHIN SPECIFICATIONS. THE INVESTIGATION REVIEWED THE CUSTOMER'S HANDLING OF PATIENT SAMPLES. THE PATIENT SAMPLE WAS CENTRIFUGED FOR 5 MINUTES WHICH MAY BE INSUFFICIENT. A GENERAL REAGENT PROBLEM WAS NOT CONFIRMED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. PRODUCT LABELING STATES "PLEASE NOTE - THE MEASURED CEA VALUE OF A PATIENT¿S SAMPLE CAN VARY DEPENDING ON THE TESTING PROCEDURE USED. THE LABORATORY FINDING MUST THEREFORE ALWAYS CONTAIN A STATEMENT ON THE CEA ASSAY METHOD USED. CEA VALUES DETERMINED ON PATIENT SAMPLES BY DIFFERENT TESTING PROCEDURES CANNOT BE DIRECTLY COMPARED WITH ONE ANOTHER AND COULD BE THE CAUSE OF ERRONEOUS MEDICAL INTERPRETATION."