ATELLICA CH

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (04-JUN-2025): SIEMENS HEALTHCARE DIAGNOSTICS CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS REVIEWED THE AVAILABLE INSTRUMENT DATA FILES, AND THE INFORMATION PROVIDED BY THE CUSTOMER. CALIBRATION WAS ACCEPTABLE, AND QUALITY CONTROL (QC) RECOVERED WITHIN RANGE ON THE EVENT DATE(S). SIEMENS REVIEW OF THE INSTRUMENT DATA INDICATED THAT THE CUSTOMER PERFORMED DILUTION CHECKS BUT DID NOT SAVE THE FACTOR. AS A RESULT, THE FACTOR REMAINED AT 1 ON 07-MAY-2025 WHEN THE DILUTION CHECK WAS PERFORMED. THE CUSTOMER STATED THAT THE ISSUE WAS RESOLVED BY PERFORMING THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) DILUTION CHECK TO OBTAIN A NEW DILUTION CHECK FACTOR. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE EVENT IS UNKNOWN. A PRODUCT ISSUE 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. CORRECTION: THE PRODUCT CODE WAS INADVERTENTLY SELECTED AS ¿CEM¿ INSTEAD OF ¿JGS¿ IN THE INITIAL MDR. SECTION D2B HAS BEEN UPDATED TO REFLECT THE CORRECT INFORMATION. INITIAL MDR 2432235-2025-00141 WAS FILED ON 30-MAY-2025.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBSERVED AN INCREASE IN ELEVATED SODIUM (NA) RESULTS ON MULTIPLE PATIENT SAMPLES, INCLUDING AN ERRONEOUSLY ELEVATED NA RESULT OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CI 1900 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL ATELLICA CI 1900 ANALYZER AND ON AN ALTERNATE ATELLICA CI 1900 ANALYZER. THE REPROCESSED RESULTS OBTAINED WERE CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. THE CUSTOMER NO LONGER RECALLED CERTAIN DETAILS, SUCH AS THE DATE OF TESTING AND THE REPROCESSED RESULT(S) FOR THE AFFECTED SAMPLE, AS THE EVENT OCCURRED SEVERAL MONTHS AGO. FOR THE OTHER ELEVATED SAMPLES, IT IS UNCLEAR WHETHER ANY ERRONEOUS RESULTS WERE OBTAINED, AS THE PATIENT RESULTS DATA WERE NOT PROVIDED TO SIEMENS AND THE CUSTOMER COULD NOT RECALL ANY DETAILS, INCLUDING SAMPLE IDENTIFIERS, DATE(S) OF TESTING, OR THE RESULTS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING AN INCREASE IN ELEVATED SODIUM (NA) RESULTS ON MULTIPLE PATIENT SAMPLES, INCLUDING AN ERRONEOUSLY ELEVATED NA RESULT OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CI 1900 ANALYZER. SIEMENS IS EVALUATING THE EVENT.