ADVIA CENTAUR CA 19-9

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF ELEVATED ADVIA CENTAUR CA 19-9 RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. MDR 1219913-2024-00502 WAS INITIALLY SUBMITTED ON 20-DEC-2024. UPDATE, 12-MAR-2025: SIEMENS HAS CONCLUDED THE INVESTIGATION. REVIEW OF CUSTOMER DATA SHOWED THAT ASSAY QUALITY CONTROL (QC) RESULTS HAD DEMONSTRATED HAD DEMONSTRATED POORER-THAN-EXPECTED PRECISION. NO UNUSUAL OBSERVATIONS WERE MADE WITH RESPECT TO CA 19-9 REAGENT PACKS, EITHER BEFORE OR AFTER USE. A SIEMENS SUPPORT ENGINEER CHECKED THE INSTRUMENT MULTIPLE TIMES. BACKGROUND-SIGNAL TESTS INDICATED THE POSSIBILITY OF INSTRUMENT CONTAMINATION, BUT NO CONTAMINATION WAS VERIFIED. SYSTEM DECONTAMINATION HAS BEEN RECOMMENDED, BUT NOT YET PERFORMED. NO SPECIFIC CAUSE FOR THE OBSERVED DISCORDANCE WAS IDENTIFIED, BUT NO SYSTEMIC PRODUCT PROBLEM WAS IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND NO FURTHER ISSUES ARE REPORTED. NOTES: 1) IN SECTION D1, PRODUCT NAME HAS BEEN CORRECTED. 2) IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF AN ELEVATED ADVIA CENTAUR CA 19-9 RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. NO ISSUES WERE NOTED WITH RESPECT TO ASSAY CALIBRATION OR QUALITY CONTROL (QC) RESULTS. SIEMENS IS INVESTIGATING.

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ADVIA CENTAUR CA 19-9 RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING CA 19-9 LOT 541. THE CUSTOMER HAS COMPLAINED ABOUT SPORADIC IMPRECISION OF ADVIA CENTAUR CA 19-9 RESULTS FOR QUALITY CONTROL (QC) AND PATIENT SAMPLES. ONE PATIENT PRODUCED AN INITIAL ELEVATED RESULT WHICH CONFLICTED WITH A LOWER RESULT OBTAINED WITH REPEAT TESTING. THE LOWER RESULT WAS CONSIDERED CORRECT. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.