ATELLICA CH CYSTATIN C_2 (CYSC_2)

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (16-FEB-2026): SIEMENS HEALTHCARE DIAGNOSTICS SERVICE OPERATIONS SUPPORT (SOS) CONCLUDED THE INVESTIGATION OF THE EVENT. NO REAGENT OR INSTRUMENT ISSUES WERE IDENTIFIED. A CUSTOMER SERVICE ENGINEER (CSE) PERFORMED ROUTINE SERVICE TASKS ON THE ATELLICA CH 930 ANALYZER. THE CUSTOMER PERFORMED A PRECISION STUDY AND THE RESULTS WERE ACCEPTABLE. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE EVENT IS UNKNOWN. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED. INITIAL MDR 2432235-2025-00241 WAS FILED ON 18-SEP-2025.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED ONE (1) DISCORDANT DEPRESSED CYSTATIN C_2 (CYSC_2) PATIENT SAMPLE RESULT WHEN PROCESSED ON AN ATELLICA CH 930 ANALYZER. THE PATIENT SAMPLE WAS PROCESSED ON AN ALTERNATE ATELLICA CH ANALYZER AND THE RESULT WAS HIGHER. IT IS UNKNOWN WHICH RESULT IS CORRECT OR IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S).THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CYSTATIN C_2 (CYSC_2) PATIENT SAMPLE RESULTS.

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING ONE (1) CYSTATIN C_2 (CYSC_2) DISCORDANT PATIENT SAMPLE RESULT OBTAINED WHEN PROCESSED ON AN ATELLICA CH 930 ANALYZER. SIEMENS IS INVESTIGATING THE EVENT.