DIMENSION

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES AFTER STANDARD A REPLACEMENT ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. QUALITY CONTROL (QC) WAS OUT OF RANGE ON THE EVENT DATE. SIEMENS IS EVALUATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED THAT ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES AFTER STANDARD A REPLACEMENT ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPROCESSED ON THE ORIGINAL SYSTEM. THE REPROCESSED RESULTS WERE HIGHER THAN THE ERRONEOUS RESULTS AND CORRELATED WITH THE PATIENT'S HISTORY. THE REPROCESSED RESULTS WERE REPORTED AS THE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS.

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2517506-2026-00054 ON 20-MAR-2026. ADDITIONAL INFORMATION (25-MAR-2026): SIEMENS CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS REVIEWED THE INSTRUMENT DATA FILES, AND THE INFORMATION PROVIDED BY THE CUSTOMER. QUALITY CONTROL (QC) WAS WITHIN RANGE BEFORE REPLACING STANDARD A (STD A), AND IT WAS OUT OF RANGE AFTER THE REPLACEMENT. THE CUSTOMER RAN QC AGAIN, WHICH RECOVERED ACCEPTABLY. SIEMENS REVIEWED THE INSTRUMENT DATA AND DETERMINED THAT THE AIR AND LIQUID VALUES OF STD A AND STANDARD B (STD B) WERE WITHIN THE NORMAL RANGE, AND THAT THE CALIBRATION WAS ACCEPTABLE WITH LYTES SLOPE IN RANGE ON THE DAY OF EVENT. THE CUSTOMER ADJUSTED THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) PUMP RATE. SIEMENS EVALUATED THE EVENT AND DETERMINED THAT STD A FLOW ISSUE POTENTIALLY CONTRIBUTED TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS, WHICH WAS CORRECTED BY AUTOMATIC PRIMING BY THE IMT SYSTEM. A PRODUCT PROBLEM 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 SIEMENS INVESTIGATION.