ATELLICA CH

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (17-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. QUALITY CONTROL (QC) PROCESSED WITH CAL ID 9051 SHOWED A HIGHER RECOVERY AND, IN SOME INSTANCES, RECOVERY OUTSIDE OF A 2 STANDARD DEVIATION (SD) PEER RANGE. THIS WAS CONSISTENT WITH THE HIGHER RECOVERY OBSERVED WITH THE AFFECTED SAMPLE, WHICH WAS PROCESSED USING CAL ID 9051. SIEMENS REVIEW OF THE CALIBRATION SHOWED SIGNIFICANT VARIABILITY WITH THE CALIBRATION COEFFICIENTS ACROSS THE DIFFERENT CALIBRATION EVENTS USING THE AFFECTED REAGENT LOT AND CHEMISTRY CALIBRATOR (CHEM CAL) LOT. THE VARIABILITY OBSERVED WITH THE CALIBRATION COEFFICIENTS WAS CONSISTENT WITH THE VARIABILITY OBSERVED WITH QC. THE CUSTOMER PERFORMED CALIBRATION MORE FREQUENTLY THAN RECOMMENDED IN THE ATELLICA CALCIUM (CA) INSTRUCTIONS FOR USE (IFU) CALIBRATION INTERVALS. SIEMENS CONCLUDED THAT AN ERRONEOUSLY ELEVATED CA RESULT ON A PATIENT SAMPLE WAS OBTAINED DUE TO THE PACK CALIBRATION (CAL ID 9051) USED TO PROCESS THE AFFECTED SAMPLE. THE CAUSE OF THE CALIBRATION ISSUE RELATED TO CAL ID 9051 IS UNKNOWN, BUT INCONSISTENT RECONSTITUTION/HANDLING OF THE ATELLICA CHEM CAL MATERIAL COULD NOT BE RULED OUT. SIEMENS DETERMINED THAT THERE WAS NO ISSUE WITH THE CA REAGENT OR A SPECIFIC REAGENT PACK/WELL. THE ISSUE WAS RESOLVED BY RECALIBRATING CA USING THE SAME REAGENT LOT. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE SIEMENS INVESTIGATION. INITIAL MDR 2432235-2025-00140 WAS FILED ON 30-MAY-2025.

Additional Manufacturer Narrative

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

Description of Event or Problem

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