DIMENSION VISTA®

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUS SODIUM (NA) RESULTS ON MULTIPLE PATIENT SAMPLES ON A DIMENSION VISTA 500 SYSTEM, RESULTING IN NEGATIVE ANION GAPS. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE DIMENSION VISTA 500 SYSTEM. THE REPROCESSED RESULTS FROM AN ALTERNATE DIMENSION VISTA 500 SYSTEM MATCHED THE PATIENT¿S CLINICAL PICTURE AND WERE REPORTED AS THE CORRECT RESULTS TO THE PHYSICIAN(S), RESULTING IN POSITIVE ANION GAPS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS SODIUM (NA) RESULTS.

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING ERRONEOUS SODIUM (NA) RESULTS OBTAINED ON MULTIPLE PATIENT SAMPLES ON A DIMENSION VISTA 500 SYSTEM, RESULTING IN NEGATIVE ANION GAPS. SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC REVIEWED THE AVAILABLE INSTRUMENT DATA FILES AND THE INFORMATION PROVIDED BY THE CUSTOMER. A REVIEW OF THE INSTRUMENT DATA INDICATED AN INTEGRATED MULTISENSOR TECHNOLOGY (IMT) DRIFT ERROR ON THE EVENT DATE. CALIBRATION WAS ACCEPTABLE. QUALITY CONTROL (QC) RECOVERY WAS WITHIN THE CUSTOMER¿S EXPECTED RANGES, INDICATING THAT THE NA ASSAY WAS PERFORMING ACCEPTABLY. HSC INDICATED THAT THE ISSUE IS CONSISTENT WITH EXCESSIVE DRIFT THAT OCCURRED AFTER A CLEAN CYCLE, AS THE SENSOR DID NOT RECOVER FROM RESIDUAL BLEACH BASED ON THE OCCURRENCE OF AN IMT DRIFT ERROR. THE SYSTEM AUTOMATICALLY RECOVERED WITHOUT ANY SERVICE ACTIONS. THE CAUSE OF THE EVENT IS UNKNOWN. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.