ATELLICA CH

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING ERRONEOUS CALCIUM (CA) RESULTS OBTAINED ON THREE (3) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. SIEMENS IS EVALUATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUS CALCIUM (CA) RESULTS ON THREE (3) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN AND THE RESULTS WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE REPROCESSED RESULTS OBTAINED WERE CONSIDERED CORRECT. THE CORRECTED REPORTS WERE NOT ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS CALCIUM (CA) RESULTS.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (27-FEB-2025): SIEMENS HEALTHCARE DIAGNOSTICS 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 THAT THE CALCIUM (CA) ASSAY WAS PERFORMING ACCEPTABLY. A REVIEW OF CALIBRATION DATA SHOWED THAT THE CALIBRATION USED TO PROCESS THE SAMPLES WITH ERRONEOUS CA RESULTS HAD A HIGHER C1 CALIBRATION COEFFICIENT AND SIGNAL RESPONSE WHEN COMPARED TO OTHER CALIBRATION EVENTS USING THE SAME REAGENT. SIEMENS CONCLUDED THAT THE CAUSE OF THE ERRONEOUS RESULTS WAS THE CALIBRATION USED TO PROCESS THE AFFECTED SAMPLES. THE ISSUE WAS RESOLVED BY RECALIBRATING THE CA ASSAY USING THE SAME REAGENT LOT, WHICH WAS PART OF STANDARD TROUBLESHOOTING PROCEDURES. 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. INITIAL MDR 2432235-2025-00040 WAS FILED ON 06-FEB-2025.