ADVIA CENTAUR CA 19-9

Additional Manufacturer Narrative

SIEMENS FILED INITIAL MDR 1219913-2025-00044 ON 28-FEB-2025. ADDITIONAL INFORMATION (05-MAR-2025): SIEMENS HEALTHCARE DIAGNOSTICS HAS CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS EVALUATED THE INSTRUMENT DATA, AND THE INFORMATION PROVIDED BY THE CUSTOMER. THE ASSAY'S INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, UNDER THE EXPECTED VALUES SECTION: ¿3.7% OF SAMPLES FROM NORMAL PATIENTS RECOVERED >37 U/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 THE 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.¿ BASED ON THE AVAILABLE INFORMATION, A SPECIFIC CAUSE FOR THE DISCORDANT RESULT WAS UNABLE TO BE DETERMINED. A PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND NO FURTHER ACTIONS ARE REQUIRED. NOTE: IN SECTION H6, CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED AN OBSERVATION OF ELEVATED ADVIA CENTAUR XPT CA 19-9 RESULT, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING ON THREE ALTERNATE METHODS. QUALITY CONTROLS (QC) RECOVERED WITHIN THE LABORATORY ESTABLISHED RANGES. 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 ISSUE.

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ADVIA CENTAUR XPT CA 19-9 RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING ON THREE ALTERNATE METHODS. AN INITIAL ELEVATED ADVIA CENTAUR XPT CA 19-9 RESULT WAS OBTAINED FOR A 45-YEAR-OLD FEMALE PATIENT. THIS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON THE ORIGINAL INSTRUMENT AND OBTAINED A SIMILAR ELEVATED RESULT. THE CUSTOMER THEN REPEATED THE SAMPLE ON THREE (3) ALTERNATE INSTRUMENTS AND OBTAINED A RESULT ABOVE THE REFERENCE RANGE FOR ALTERNATE INSTRUMENT 2 AND LOW (NEGATIVE) RESULTS FROM ALTERNATE INSTRUMENT 1 AND ALTERNATE INSTRUMENT 3 WHICH WERE CONSIDERED CORRECT, 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.