DIMENSION

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS OBTAINED ON MULTIPLE PATIENT SAMPLES ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. SIEMENS HEALTHCARE DIAGNOSTICS CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS REVIEWED THE AVAILABLE INFORMATION PROVIDED BY THE CUSTOMER. QUALITY CONTROL (QC) RECOVERED WITHIN THE CUSTOMER'S EXPECTED RANGES PRIOR TO RUNNING PATIENT SAMPLES. THE CUSTOMER PERFORMED INTEGRATED MULTISENSOR TECHNOLOGY (IMT) SYSTEM CLEAN AND REPLACED THE IMT SENSOR. THE CUSTOMER RESET THE CORRECTION FACTOR AND REPLACED SALT BRIDGE AS PER SIEMENS RECOMMENDATIONS. THE CUSTOMER RAN QC, WHICH PASSED. SIEMENS CONCLUDED THE EVENT AND DETERMINED THAT THE FLOW ISSUE THROUGH IMT POTENTIALLY CONTRIBUTED TO THE EVENT. A PRODUCT ISSUE WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY OBTAINED ERRONEOUSLY DEPRESSED SODIUM (NA) RESULTS ON MULTIPLE PATIENT SAMPLES ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. IT IS UNKNOWN IF THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THE SAMPLES WERE REPEATED TO CONFIRM THE CORRECT RESULTS. THE CUSTOMER DID NOT PROVIDE PATIENT SAMPLE DATA, INCLUDING SAMPLE IDENTIFIERS, ERRONEOUS RESULTS, AND CORRECT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.