ATELLICA IM CA 19-9

Additional Manufacturer Narrative

MDR 1219913-2024-00425 WAS INITIALLY FILED ON 08-OCT-2024. ADDITIONAL INFORMATION (6-JAN-2025): SIEMENS HEALTHCARE DIAGNOSTICS HAS CONCLUDED THE INVESTIGATION OF THE EVENT. A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF REPRODUCIBLY ELEVATED ATELLICA IM CA 19-9 RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING ON AN ALTERNATE TESTING METHOD. SIEMENS EVALUATED THE INSTRUMENT DATA AND THE INFORMATION PROVIDED BY THE CUSTOMER. SIEMENS EVALUATED SAMPLE WITH SID: (B)(6) DRAWN FROM THE AFFECTED PATIENT AND DETERMINED THERE WAS AN INTERFERENT IN THE SAMPLE BUT COULD NOT BUT COULD NOT IDENTIFY THE SPECIFIC SUBSTANCE CAUSING THE INTERFERENCE. THE ASSAY'S INSTRUCTIONS FOR USE (IFU) STATED THE FOLLOWING, UNDER LIMITATIONS SECTION: ¿DO NOT USE THE ATELLICA IM CA 19 9 ASSAY AS A SCREENING TEST OR FOR DIAGNOSIS. DO NOT PREDICT DISEASE RECURRENCE SOLELY ON LEVELS OF ATELLICA IM CA 19 9. NORMAL LEVELS OF ATELLICA IM CA 19 9 DO NOT ALWAYS PRECLUDE THE PRESENCE OF DISEASE. DO NOT INTERPRET SERUM LEVELS OF CA 19 9 AS ABSOLUTE EVIDENCE OF THE PRESENCE OR THE ABSENCE OF MALIGNANT DISEASE. BEFORE TREATMENT, PATIENTS WITH CONFIRMED GI CARCINOMA FREQUENTLY HAVE LEVELS OF CA 19 9 WITHIN THE RANGE OBSERVED IN HEALTHY INDIVIDUALS. ADDITIONALLY, ELEVATED LEVELS OF CA 19 9 CAN BE OBSERVED IN PATIENTS WITH NONMALIGNANT DISEASES. MEASUREMENTS OF CA 19 9 SHOULD ALWAYS BE USED IN CONJUNCTION WITH OTHER DIAGNOSTIC PROCEDURES, INCLUDING INFORMATION FROM THE PATIENT'S CLINICAL EVALUATION.¿ BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT IS CONSISTENT WITH A SAMPLE SPECIFIC INTERFERENT. A PRODUCT PROBLEM WAS NOT 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. MDR 1219913-2024-00426 AND MDR 1219913-2024-00463 WERE FILED TO ADDRESS THE DISCORDANT OBSERVATIONS OBTAINED WITH SAMPLE ID: (B)(6) ON 04-SEP-2024 AND SAMPLE ID: (B)(6) ON 29-SEP-2024, RESPECTIVELY.

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF REPRODUCIBLY ELEVATED ATELLICA IM CA 19-9 RESULTS WITH LOT# 539 WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING ON AN ALTERNATE TESTING METHOD. QUALITY CONTROL (QC) RECOVERED WITHIN CUSTOMER 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 EVALUATING THE EVENT. NOTE: THIS MDR IS FILED TO ADDRESS THE DISCORDANT OBSERVATION OBTAINED WITH SAMPLE ID (B)(6) ON (B)(6) 2024. A SEPARATE MDR WILL BE FILED TO ADDRESS THE DISCORDANT OBSERVATION OBTAINED WITH SAMPLE ID (B)(6) ON (B)(6) 2024.

Description of Event or Problem

THE CUSTOMER REPORTS OBSERVATION OF ELEVATED ATELLICA IM CA 19-9 RESULTS ON TWO SAMPLES FROM THE SAME PATIENT (61-YEAR-OLD FEMALE) WITH LOT# 539 WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING ON AN ALTERNATE TESTING METHOD. THE PATIENT WAS TESTED, THE INITIAL ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. A NEW SAMPLE WAS DRAWN AND TESTED WHICH PRODUCED AN ELEVATED RESULT. THE SAMPLE WAS SENT TO OTHER LAB FOR ALTERNATE-METHOD TESTING WHICH RETURNED NORMAL-RANGE RESULT. THE REGION SHARED TEST DATA THAT WERE PERFORMED FOR INVESTIGATION/TROUBLESHOOTING PURPOSES. THERE ARE NO ALLEGATIONS OF ANY PATIENT HARM RESULTING FROM THE OBSERVED RESULT DISCORDANCE.