DIMENSION VISTA V-LYTE INTEGRATED MULTISENSOR NA+ K+ CL-

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT ON ONE (1) PATIENT SAMPLE ON THE DIMENSION VISTA 500 SYSTEM. THE ERRONEOUSLY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THIS SAMPLE COULD NOT BE REPROCESSED DUE TO QUANTITY NOT SUFFICIENT. A NEW SAMPLE WAS DRAWN AND PROCESSED ON AN ALTERNATE DIMENSION VISTA 500 SYSTEM. A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT.

Additional Manufacturer Narrative

A UNITED STATES CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT ON ONE (1) PATIENT SAMPLE ON A DIMENSION VISTA 500 SYSTEM. SIEMENS HEALTHCARE DIAGNOSTICS SERVICE OPERATIONS SUPPORT (SOS) CONCLUDED THE INVESTIGATION OF THE EVENT. SOS EVALUATED THE INFORMATION PROVIDED BY THE CUSTOMER. NO REAGENT OR INSTRUMENT ISSUES WERE IDENTIFIED. QUALITY CONTROL (QC) RECOVERED WITHIN THE CUSTOMER¿S LABORATORY RANGES AT THE TIME OF THE EVENT. 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.