ATELLICA IM CA 19-9 (CA19-9)

Description of Event or Problem

THE CUSTOMER OBTAINED A DEPRESSED ATELLICA IM CA 19-9 RESULT ON A PATIENT SAMPLE THAT WAS HIGHER WHEN THE SAMPLE WAS TESTED WITH AN ALTERNATE METHOD. IT IS UNKNOWN IF THE DEPRESSED ATELLICA IM CA 19-9 RESULT WAS REPORTED TO THE PHYSICIAN. THERE IS NO INDICATION OF A CANCER DIAGNOSIS, HOWEVER THE ATELLICA IM CA 19-9 RESULT WAS EXPECTED TO BE HIGHER BECAUSE THE PATIENT HAD AN ELEVATED CA50 RESULT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

Additional Manufacturer Narrative

THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES (OUS). THE OUS CUSTOMER OBTAINED A DEPRESSED ATELLICA IM CA 19-9 RESULT ON A PATIENT SAMPLE THAT WAS HIGHER WHEN THE SAMPLE WAS TESTED WITH AN ALTERNATE METHOD. IT IS UNKNOWN IF THE DEPRESSED ATELLICA IM CA 19-9 RESULT WAS REPORTED TO THE PHYSICIAN. THERE IS NO INDICATION OF A CANCER DIAGNOSIS, HOWEVER THE ATELLICA IM CA 19-9 RESULT WAS EXPECTED TO BE HIGHER BECAUSE THE PATIENT HAD AN ELEVATED CA50 RESULT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT. 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.

Additional Manufacturer Narrative

SIEMENS INVESTIGATED AN OUTSIDE THE UNITED STATES (OUS) CUSTOMER REPORT OF A DEPRESSED ATELLICA IM CA 19-9 RESULT ON A PATIENT SAMPLE THAT WAS HIGHER WHEN THE SAMPLE WAS TESTED WITH AN ALTERNATE METHOD. THERE IS NO INDICATION OF A CANCER DIAGNOSIS, BUT THE PATIENT HAS CIRRHOSIS OF THE LIVER. THE CUSTOMER EXPECTED AN ATELLICA IM CA 19-9 RESULT WAS EXPECTED TO BE HIGHER BECAUSE THE PATIENT HAD AN ELEVATED CA50 RESULT. PATIENT MEDICATION/SUPPLEMENTATION IS UNKNOWN. ALL QUALITY CONTROL (QC) RESULTS WERE WITHIN THE NORMAL RANGES. INSTRUMENT AND REAGENT PERFORMANCE WAS RULED OUT BASED ON THE PATIENT SAMPLE RESULTS BEING REPEATABLE ON ATELLICA IM AT DIFFERENT LABS WITH DIFFERENT REAGENT LOTS. PER THE ASSAY INSTRUCTIONS FOR USE (IFU), THE INTENDED USE OF THE ATELLICA IM CA 19-9 ASSAY IS FOR IN VITRO DIAGNOSTIC USE IN THE QUANTITATIVE, SERIAL DETERMINATION OF CA 19-9 IN HUMAN SERUM AND TO AID IN THE MANAGEMENT OF PATIENTS WITH GASTROINTESTINAL (GI) CARCINOMA USING THE ATELLICA IM ANALYZER. THE TEST IS INTENDED FOR USE AS AN AID IN MONITORING PATIENTS PREVIOUSLY TREATED FOR GI CANCER, NOT FOR SCREENING OR DIAGNOSIS. WHILE CA50 AND CA 19-9 CAN BE ELEVATED IN PATIENTS WITH CIRRHOSIS OF THE LIVER, THE ATELLICA IM CA 19-9 ASSAY IS NOT INTENDED TO MONITOR PATIENTS WITH CIRRHOSIS. AS STATED IN THE EXPECTED VALUE SECTION OF THE ATELLICA IM CA 19-9 IFU ONLY 20% OF SAMPLES FROM PATIENTS WITH CIRRHOSIS HAD CA 19-9 VALUES > 37 U/ML. AS STATED IN THE LIMITATIONS SECTION OF THE ATELLICA IM CA 19-9 IFU: 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, THE CAUSE OF THE DISCORDANT RESULT CANNOT BE DETERMINED. THERE IS NO EVIDENCE OF A REAGENT OR INSTRUMENT ISSUE. THE CUSTOMER IS OPERATIONAL. SIEMENS FILED INITIAL MDR 1219913-2024-00471 ON 21-NOV-2024. IN SECTION H6 OF THIS REPORT, THE INVESTIGATION FINDING AND CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.