ATELLICA CH

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2432235-2025-00315 ON 12-DEC-2025. ADDITIONAL INFORMATION (16-DEC-2025): SIEMENS REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER, AND THE AVAILABLE INSTRUMENT DATA FILES. SIEMENS' REVIEW OF THE INSTRUMENT DATA INDICATED PRESENCE OF BUBBLES IN SAMPLE. THERE IS NO REPORTED ISSUE WITH QUALITY CONTROL RECOVERY AND NO REPORTED BEHAVIOR WITH OTHER PATIENT SAMPLES. SIEMENS EVALUATED THE EVENT AND DETERMINED THAT THE CAUSE OF THE BEHAVIOR IS DUE TO SAMPLE QUALITY CONSISTENT WITH PRESENCE OF BUBBLES AND/OR FIBRIN. A PRODUCT PROBLEM WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE SIEMENS INVESTIGATION.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. CALIBRATION AND QUALITY CONTROL (QC) WERE ACCEPTABLE ON THE DAY OF THE EVENT. SIEMENS IS EVALUATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBSERVED AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON TWO DIFFERENT ALTERNATE ATELLICA CH 930 ANALYZERS. THE REPEAT RESULTS FROM THE ALTERNATE ATELLICA CH 930 ANALYZERS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.