ATELLICA CH CALCIUM (CA)

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (20-AUG-2025): SIEMENS HEALTHCARE DIAGNOSTICS SERVICE OPERATIONS SUPPORT (SOS) CONCLUDED THE INVESTIGATION OF THE EVENT. SOS REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER AND THE DATA FROM THE INSTRUMENT. NO REAGENT OR INSTRUMENT ISSUES WERE IDENTIFIED. QUALITY CONTROL (QC) RECOVERED WITHIN THE CUSTOMER¿S LABORATORY RANGES AT THE TIME OF THE EVENT. SOS REVIEWED THE CALIBRATION DATA FOR CALCIUM (CA) ON AN ATELLICA CH 930 ANALYZER AND OBSERVED VARIABILITY FOR THE C1 CALIBRATION COEFFICIENT ACROSS THE DIFFERENT CALIBRATION EVENTS. THE CUSTOMER PERFORMED A NEW CALIBRATION PRIOR TO REPEAT TESTING WHICH PRODUCED ACCEPTABLE RESULTS. BASED ON THE AVAILABLE INFORMATION, 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 2432235-2025-00196 WAS FILED ON 23-JUL-2025.

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY ELEVATED CALCIUM (CA) PATIENT SAMPLE RESULT WAS OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED CALCIUM (CA) PATIENT SAMPLE RESULT.