ELECSYS CEA

Additional Manufacturer Narrative

NA.

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CEA (CEA) ON A COBAS 8000 E 602 MODULE. THE INITIAL RESULT WAS 0.9 NG/ML. THE REPEAT RESULT WAS 0.9 NG/ML. THE CUSTOMER¿S INITIAL AND REPEAT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE PHYSICIAN QUESTIONED THEM AS THE CEA RESULTS DECREASED ALTHOUGH THE PATIENT HAD NOT RECEIVED ANY TREATMENT. THE PHYSICIAN REQUESTED ADDITIONAL TESTING OF THE PATIENT SAMPLE. THE SAMPLE WAS SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED BETWEEN THE CUSTOMER¿S E602 MODULE AND AN E602 MODULE USED AT THE INVESTIGATION SITE. THE RESULT FROM THE INVESTIGATION SITE WAS 0.46 NG/ML. THE CUSTOMER'S E602 MODULE SERIAL NUMBER WAS (B)(4).

Additional Manufacturer Narrative

THERE WAS INSUFFICENT SAMPLE MATERIAL REMAINING FOR FURTHER INVESTIGATION. THE PATIENT TAKES STIVARGA. IT WAS NOTED THAT STIVARGA (REGORAFENIB) IS USED FOR THE TREATMENT OF METASTATIC COLORECTAL CANCER; IT IS NOT CLEAR WHY THE PHYSICIAN THINKS THAT "THAT CEA LEVELS DECLINED DESPITE BEING UNTREATED." NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE REAGENT PERFORMED WITHIN SPECIFICATIONS. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.