DIMENSION EXL WITH LM

Description of Event or Problem

A DISCORDANT POTASSIUM (K) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT K RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED IT. THE CUSTOMER RERAN THE SAMPLE (1ST REPEAT) ON THE SAME INSTRUMENT AND THAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPEATED THE SAMPLE LATER THAT DAY (2ND REPEAT) ON THE SAME INSTRUMENT, WHICH RESULTED LOWER. THE SAMPLE WAS ALSO REPEATED (3RD REPEAT) ON AN ALTERNATE SYSTEM, WHICH RESULTED LOWER. THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS REDRAWN AND THE SAMPLE WAS TESTED ON AN ALTERNATE SYSTEM, WHICH RESULTED LOWER. THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT K RESULTS.

Additional Manufacturer Narrative

THE SIEMENS CUSTOMER CARE CENTER (CCC) WAS CONTACTED BY THE CUSTOMER. THE CCC EVALUATED THE INSTRUMENT DATA AND INSTRUCTED THE CUSTOMER TO CHECK THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) PUMPING RATE AND TO REPLACE THE QUIKLYTE SENSOR. THE CCC RECOMMENDED THAT THE CUSTOMER ENSURE TUBES ARE FULL DRAWS, TO PREVENT PLATELETS FROM FORMING, WHICH CAN CAUSE ELEVATED POTASSIUM RESULTS ON INITIAL ASPIRATION. THE CAUSE OF THE ELEVATED POTASSIUM RESULTS IS UNKNOWN. THE CUSTOMER SUCCESSFULLY RAN PRECISION AND QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.