DIMENSION VISTA

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING DISCORDANT ELEVATED SODIUM (NA) RESULTS ON PATIENT SAMPLES ON A DIMENSION VISTA 1500 INTELLIGENT LAB SYSTEM. SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC REVIEWED THE INSTRUMENT DATA FILES AND THE INFORMATION PROVIDED BY THE CUSTOMER. QUALITY CONTROL (QC) AND CALIBRATION RECOVERY WERE WITHIN THE CUSTOMER¿S EXPECTED RANGES. HSC REVIEWED INTEGRATED MULTISENSOR TECHNOLOGY (IMT) ANALYZER DATA AND OBSERVED DILUTION CHECK FACTOR, AIR VALUES OF STANDARD (STD) A AND STD B AND PUMP RATE WERE WITHIN THE NORMAL RANGE ON THE DAY OF EVENT AND OBSERVED NO ERRORS RELATED TO IMT. THE CUSTOMER IS OPERATIONAL AFTER REPLACING THE IMT SENSOR WHICH WAS A PART OF STANDARD TROUBLESHOOTING. THE CAUSE OF THE EVENT IS UNKNOWN. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED DISCORDANT ELEVATED SODIUM (NA) RESULTS ON PATIENT SAMPLES ON A DIMENSION VISTA 1500 INTELLIGENT LAB SYSTEM. THE PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE QUESTIONED. IT IS UNKNOWN IF THE SAMPLES WERE REPEATED AND CORRECTED REPORTS WERE ISSUED. THE CUSTOMER DID NOT PROVIDE THE PATIENT DATA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED SODIUM (NA) RESULTS.