ADVIA CENTAUR CA 19-9 (CA19-9)

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES (OUS) REPORTED OBSERVATION OF A DISCORDANT ELEVATED ADVIA CENTAUR XP CA 19-9 RESULT. SIEMENS INVESTIGATION CONFIRMED AN AVERAGE POSITIVE BIAS OF 56.4% WITH A SAMPLE POPULATION FROM THE ASIA PACIFIC REGION AND ATELLICA IM AND ADVIA CENTAUR 19-9 ASSAY KIT LOTS ENDING IN 535 AS COMPARED TO PREVIOUS LOTS. HOWEVER, INVESTIGATION DID NOT CONFIRM COMMERCIAL QUALITY CONTROL RESULTS OUTSIDE OF RANGE. URGENT MEDICAL DEVICE CORRECTION (UMDC) AIMC 24-14.A.US AND URGENT FIELD SAFETY NOTICE (UFSN) AIMC 24-14.A.OUS WERE DISTRIBUTED TO CUSTOMERS WHO HAVE RECEIVED THE AFFECTED PRODUCT TO NOTIFY THEM OF THE BIAS. THE COMMUNICATION ADVISES CUSTOMERS TO DISCONTINUE USE OF THE AFFECTED PRODUCT. NOTE: THIS CUSTOMER ACKNOWLEDGED THE UFSN ON 07-AUG-2024, HOWEVER A TECHNICIAN INADVERTENTLY USED THE PRODUCT, WHICH RESULTED IN THIS EVENT. CUSTOMER HAS SINCE RECEIVED A REPLACEMENT LOT AND IS OPERATIONAL.

Description of Event or Problem

THE CUSTOMER CONTACTED SIEMENS TO REPORT AN OBSERVATION OF A DISCORDANT (ELEVATED) ADVIA CENTAUR XP CA 19-9, LOT 535 RESULT ON A SAMPLE FROM A PATIENT WITH NO CLINICAL HISTORY OF CANCER. THE PATIENT SAMPLE WAS INITIALLY TESTED WITH ADVIA CENTAUR XP CA 19-9, LOT 535 AND RESULTED ABOVE THE EXPECTED NORMAL VALUE RANGE (>37 U/ML). THE RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. THE PATIENT WAS TESTED FOR CA19-9 AT ANOTHER HOSPITAL AND THE RESULT WAS WITHIN NORMAL RANGE. THERE ARE NO REPORTS ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.