DIMENSION VISTA 1500

Additional Manufacturer Narrative

THE INITIAL MDR 1226181-2015-00026 WAS FILED ON JANUARY 15, 2015.CORRECTED INFORMATION (01/01/2015): IN ADDITION TO ELEVATED SODIUM AND CHLORIDE RESULTS, A DISCORDANT FALSELY ELEVATED K RESULT WAS OBTAINED ON ONE PATIENT SAMPLE.

Description of Event or Problem

A DISCORDANT, FALSELY ELEVATED POTASSIUM (K) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT, RESULTING LOWER THAN THE INITIAL RESULT. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S).THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED K RESULTS.

Description of Event or Problem

DISCORDANT, FALSELY ELEVATED SODIUM (NA) AND CHLORIDE (CL) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOR NA AND CL ON THE SAME INSTRUMENT, BOTH RESULTING LOWER THAN THE INITIAL RESULTS. THE SAMPLE WAS ALSO REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT FOR NA RESULTING SAME AS THE FIRST REPEAT RESULT. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED NA AND CL RESULTS.

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) SPECIALIST. THE CCC DIALED INTO THE SYSTEM REMOTELY AND RAN CHECK ONE ON INTEGRATED MULTISENSOR TECHNOLOGY (IMT), WHICH FAILED WITH TWO ERRORS. THE CCC CHECKED FLUIDS, AIR IN PATHS AND WORKING TRANSDUCER, AFTER WHICH TWO MORE CHECKS WERE RUN THAT FAILED FOR THE SAME ERRORS. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) SPECIALIST WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE EVALUATED THE INSTRUMENT AND DISCOVERED THAT IMT TUBING WAS HEAVILY WORN WITH FLOW RATE BELOW THE ACCEPTABLE RANGE. THE CSE REPLACED THE TUBING WITH FLOW RECOVERING WITHIN ACCEPTABLE RANGE. THE CSE THEN PERFORMED A CORRELATION BETWEEN THE DIMENSION VISTA INSTRUMENTS WITH CONTROL MATERIAL, WHICH WAS WITHIN ACCEPTABLE RANGE. THE CAUSE OF THE DISCORDANT FALSELY ELEVATED NA AND CL RESULTS ON SAMPLE FROM ONE PATIENT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.