ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA)

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. CEA LOT 218 WAS IN USE AT THE TIME. ELEVATED RESULTS WERE OBSERVED FOR 18 PATIENTS. THE RESULTS WERE VERY HIGH, AND WERE NOT REPORTED TO PHYSICIANS. THE SAME SAMPLES WERE REPEAT-TESTED USING ANOTHER REAGENT PACK FROM THE SAME LOT, AND ALL OF THE RESULTS WERE MUCH LOWER. THESE LOWER RESULTS WERE CONSISTENT WITH CLINICAL EXPECTATION, AND REPORTED TO PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ELEVATED CEA RESULTS.

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF DISCORDANT ELEVATED CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS FOR EIGHTEEN PATIENT SAMPLES WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. THERE WERE NO VISIBLE ISSUES (CLUMPS, PRECIPITATE) WITH THE REAGENT PACK WHICH PRODUCED THE DISCORDANT RESULTS. NO PACK CALIBRATION WAS PERFORMED USING THIS PACK. IT WAS NOTED THAT ONE LEVEL OF THE BIO-RAD QUALITY CONTROL (QC) SAMPLES TESTED USING THIS PACK HAD BEEN ABOVE EXPECTED RANGE. NO INSTRUMENT ERRORS WERE OBSERVED. SIEMENS IS EVALUATING THE EVENT.

Additional Manufacturer Narrative

MDR 1219913-2024-00309 WAS INITIALLY FILED ON 16-MAY-2024. ADDITIONAL INFORMATION (18-JUN-2024): SIEMENS HEALTHCARE DIAGNOSTICS HAS CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS EVALUATED THE INSTRUMENT DATA AND THE INFORMATION PROVIDED BY THE CUSTOMER. NO INSTRUMENT ERRORS WERE OBSERVED DURING THIS EVENT. THE REAGENT USED FOR TESTING WERE ASSESSED AND NO ABNORMALITIES WERE OBSERVED. REAGENT AND INSTRUMENT ISSUES WERE RULED OUT BASED ON QUALITY CONTROL (QC) RECOVERY WITHIN ACCEPTABLE RANGES, INSTRUMENT DATA, AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULTS WAS UNABLE TO BE DETERMINED. A PRODUCT PROBLEM WAS NOT IDENTIFIED. IN SECTION H6, THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES WERE UPDATED.