ELECSYS CEA

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED HIGH RESULTS FROM 2 SAMPLES FROM 1 PATIENT NOT CORRESPONDING TO THE CLINICAL PICTURE WHEN TESTED FOR ELECSYS CEA (CEA) ON A COBAS E 801 ANALYTICAL UNIT. SAMPLE 1 RESULT FROM THE E801 UNIT WAS 19.8 NG/ML (NORMAL REFERENCE RANGE 0 ¿ 5 NG/ML). THE SAMPLE WAS REPEATED ON THE SAME UNIT WITH A RESULT OF 20.7 NG/ML. THE SAMPLE WAS REPEATED ON A DIFFERENT E801 MODULE WITH A RESULT OF 20 NG/ML. THE RESULT FROM THE SIEMENS METHOD WAS 3.53 NG/ML (NORMAL REFERENCE RANGE 0 ¿ 10 NG/ML). ON 28-JUL-2022 SAMPLE 2 RESULT FROM THE E801 UNIT WAS 20.3 NG/ML (NORMAL REFERENCE RANGE 0 ¿ 5 NG/ML). THE SAMPLE WAS REPEATED ON A DIFFERENT E801 MODULE WITH A RESULT OF 20.8 NG/ML. THE RESULT FROM THE SIEMENS METHOD WAS 3.75 NG/ML (NORMAL REFERENCE RANGE 0 ¿ 10 NG/ML). THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT HAD BEEN TREATED AFTER RADICAL RESECTION OF ESOPHAGEAL SQUAMOUS CELL CARCINOMA WITH ALBUMIN PACLITAXEL AND SINTILIMAB FOR 4 CYCLES OF TREATMENT THEN SINTILIMAB FOR 16 CYCLES OF TREATMENT. BASED ON THE TREATMENT RECEIVED, THE DOCTOR THOUGHT THE CEA RESULTS SHOULD BE WITHIN THE NORMAL RANGE. THE E801 UNIT SERIAL NUMBER WAS (B)(4). THE SERIAL NUMBER FOR THE OTHER E801 MODULE WAS NOT PROVIDED.

Additional Manufacturer Narrative

THE SAMPLES WERE REQUESTED FOR INVESTIGATION.

Additional Manufacturer Narrative

SECTION D4, EXPIRATION DATE WAS UPDATED. QC RESULTS DO NOT INDICATE AN ISSUE. SAMPLE MATERIAL WAS RECEIVED FOR INVESTIGATION AND WAS TESTED ON AN E801 MODULE WITH CEA REAGENT LOT: 607340. THE CUSTOMER'S RESULTS WERE REPRODUCIBLE. THE REPEAT RESULTS AT THE INVESTIGATION SITE WERE 19.7 NG/ML AND 20.2 NG/ML. THE SAMPLE MATERIAL UNDERWENT POLYETHYLENE GLYCOL (PEG) PRECIPITATION TESTING. THE RESULTS FROM THE INVESTIGATION DO NOT INDICATE AN INTERFERENCE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

SECTION D4, LOT NUMBER WAS UPDATED.