ATELLICA CH CALCIUM (CA)

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (01-DEC-2025): SIEMENS HEALTHCARE DIAGNOSTICS SERVICE OPERATIONS SUPPORT (SOS) CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER AND INSTRUMENT DATA FILES. QUALITY CONTROL (QC) RECOVERED WITHIN THE CUSTOMER¿S EXPECTED RANGES, INDICATING THE CALCIUM (CA) ASSAY WAS PERFORMING ACCEPTABLY. SOS REVIEWED THE CALIBRATION DATA FOR CA AND OBSERVED THE INITIAL AND REPEAT RESULT WERE PROCESSED USING DIFFERENT CALIBRATION EVENTS. THE CALIBRATION DATA SHOWED THAT THE CALIBRATION USED TO PROCESS THE SAMPLE INITIALLY HAD A HIGHER C1 CALIBRATION COEFFICIENT AND SIGNAL RESPONSE WHEN COMPARED TO OTHER CALIBRATION EVENTS USING THE SAME REAGENT. SIEMENS CONCLUDED THE CAUSE OF THE ERRONEOUS RESULT WAS THE CALIBRATION USED TO PROCESS THE AFFECTED SAMPLE. THE ISSUE WAS RESOLVED BY RECALIBRATING THE CA ASSAY USING THE SAME REAGENT LOT, WHICH WAS PART OF STANDARD TROUBLESHOOTING PROCEDURES. THE CAUSE OF THE CALIBRATION DIFFERENCES CANNOT BE DETERMINED. THE CUSTOMER IS OPERATIONAL. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE SIEMENS INVESTIGATION. INITIAL MDR 2432235-2025-00224 WAS FILED ON 26-AUG-2025. MDR 2432235-2025-00224 SUPPLEMENTAL REPORT 1 WAS FILED ON 19-SEP-2025.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS ONE (1) CALCIUM (CA) DISCORDANT PATIENT SAMPLE RESULT WAS OBTAINED WHEN PROCESSED TWICE ON AN ATELLICA CH 930 ANALYZER. IT IS UNKNOWN WHICH OF THE RESULTS 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 CALCIUM (CA) PATIENT SAMPLE RESULT.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (26-AUG-2025): THE INSTRUMENT WAS NOT SERVICED BY A THIRD PARTY. SECTION D8 WAS UPDATED WITH THE INFORMATION. INITIAL MDR 2432235-2025-00224 WAS FILED ON 26-AUG-2025.