ATELLICA CH A-LYTE INTEGRATED MULTISENSOR (IMT NA K CL)

Additional Manufacturer Narrative

SIEMENS HEALTHCARE DIAGNOSTICS SERVICE OPERATIONS SUPPORT (SOS) CONCLUDED THE INVESTIGATION OF THE EVENT. SOS REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER. QUALITY CONTROL (QC) RECOVERED WITHIN THE CUSTOMER'S ACCEPTABLE RANGES. NO REAGENT NOR INSTRUMENT ISSUES WERE IDENTIFIED. 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. SECTION H6 HAS BEEN UPDATED TO REFLECT THE SOS INVESTIGATION. SECTION G4 HAS BEEN REVISED WITH THE CORRECT 510K NUMBER. SECTION D2A HAS BEEN REVISED WITH THE CORRECT PRODUCT CODE. INITIAL MDR WAS FILED ON 05-DEC-2024.

Description of Event or Problem

THE CUSTOMER REPORTED AN ERRONEOUSLY DEPRESSED PATIENT SAMPLE RESULT WITH SODIUM (NA) WAS OBTAINED ON AN ATELLICA ® CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED PATIENT SAMPLE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ABL RADIOMETER (BLOOD GAS ANALYZER). A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA ® CH 930 ANALYZER. A SIMILAR ERRONEOUS PATIENT RESULT WAS OBTAINED AS ON THE ORIGINAL ATELLICA ® CH 930 ANALYZER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT.

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING AN ERRONEOUSLY DEPRESSED PATIENT SAMPLE RESULT WITH SODIUM (NA) ON AN ATELLICA ® CH 930 ANALYZER. SIEMENS IS INVESTIGATING THE EVENT.