ATELLICA CH A-LYTE INTEGRATED MULITSENSOR (IMT NA K CL)

Additional Manufacturer Narrative

A UNITED STATES CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS ON TWO (2) PATIENT SAMPLES USING AN A-LYTE INTEGRATED MULTISENSOR (IMT) OBTAINED ON AN ATELLICA CH 930 ANALYZER. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS OBTAINED ON TWO (2) PATIENT SAMPLES USING AN A-LYTE INTEGRATED MULTISENSOR (IMT) ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON THE SAME ATELLICA CH 930 ANALYZER. HIGHER RESULTS WERE OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (04-SEPT-2025): SIEMENS SERVICE OPERATIONS SUPPORT (SOS) CONCLUDED THE INVESTIGATION OF THE EVENT. A CUSTOMER SERVICE ENGINEER (CSE) PERFORMED MULTIPLE SERVICE ACTIONS ON THE ATELLICA CH 930 ANALYZER, AS PART OF TROUBLESHOOTING. NO OTHER DISCORDANT RESULTS WERE REPORTED AFTER THESE SERVICE ACTIONS. 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 WAS FILED ON 02-SEPT-2025.