ADVIA CENTAUR CA 19-9

Additional Manufacturer Narrative

MDR 1219913-2024-00495 WAS INITIALLY FILED ON 09-DEC-2024. ADDITIONAL INFORMATION (18-MAR-2025): SIEMENS HEALTHCARE DIAGNOSTICS HAS CONCLUDED THE INVESTIGATION OF THE EVENT. A CUSTOMER FROM OUTSIDE THE UNITED STATES (OUS) REPORTED OBSERVATION OF AN ELEVATED ADVIA CENTAUR XP CA 19-9 RESULT, WHICH WAS DISCORDANT RELATIVE TO CLINICAL EXPECTATION AND REPEAT TESTING ON AN ALTERNATE METHOD. SIEMENS EVALUATED THE INSTRUMENT DATA, AND THE INFORMATION PROVIDED BY THE CUSTOMER. THE PATIENT¿S CURRENT MEDICATIONS AND SUPPLEMENTS WERE NOT PROVIDED. THE PATIENT SAMPLE WAS RETURNED TO SIEMENS FOR FURTHER INVESTIGATION. THE SAMPLE WAS TESTED BOTH TO CONFIRM RECOVERY AND WITH BLOCKERS DESIGNED TO PREVENT INTERFERENCE. THE RESULT WAS SIGNIFICANTLY LOWER INDICATING A SAMPLE-SPECIFIC INTERFERENT. THE ASSAY'S INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, UNDER EXPECTED VALUES SECTION: ¿3.7% OF SAMPLES FROM NORMAL PATIENTS RECOVERED >37 IU/ML SO A CERTAIN NUMBER OF ELEVATED RESULTS FROM NORMAL PATIENTS CAN BE EXPECTED FOR THIS ASSAY.¿ THE ASSAY'S INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, UNDER LIMITATIONS SECTION: ¿THE ASSAY IS NOT SUPPOSED TO BE USED AS A SCREENING TEST OR FOR DIAGNOSIS. ELEVATED LEVELS OF CA 19-9 CAN BE OBSERVED IN PATIENTS WITH NONMALIGNANT DISEASES. THE CONCENTRATION OF CA 19-9 IN A GIVEN SPECIMEN DETERMINED WITH ASSAYS FROM DIFFERENT MANUFACTURERS CAN VARY BECAUSE OF DIFFERENCES IN ASSAY METHODS, CALIBRATION, AND REAGENT SPECIFICITY. HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBULINS, INTERFERING WITH IN VITRO IMMUNOASSAYS.¿ BASED ON THE AVAILABLE INFORMATION, ALTHOUGH A SAMPLE-SPECIFIC INTERFERENT CONTRIBUTED TO THE ISSUE, THE CAUSE OF THE DISCORDANT RESULT CANNOT BE DETERMINED. A PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.

Additional Manufacturer Narrative

THE CUSTOMER FROM OUTSIDE THE UNITED STATES (OUS) REPORTS OBSERVATION OF AN ELEVATED ADVIA CENTAUR XP CA 19-9 RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE METHOD TESTING. THE ASSAY'S INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, UNDER INTERPRETATION OF RESULTS: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ADVIA CENTAUR XP CA 19-9 RESULT FOR A PATIENT SAMPLE WHICH WAS DISCORDANT RELATIVE TO ALTERNATE METHOD TESTING WHEN USING REAGENT LOT 539. AN INITIAL ELEVATED ADVIA CENTAUR CA 19-9 RESULT WAS OBTAINED AND REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS THEN REPEATED USING AN ALTERNATE TESTING METHOD AND THE RESULT OBTAINED WAS MUCH LOWER. THIS RESULT WAS CONSIDERED CORRECT AS IT MATCHED THE CLINICAL PICTURE OF THE PATIENT AND A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.