Description of Event or Problem · 1
USER EXPERIENCING ISSUES WITH SODIUM SINCE 2008. LOW RESULTS RECEIVED ABOUT 4 DAYS LATER. SEVEN PATIENT SAMPLES ARE KNOWN TO BE AFFECTED. SIX EXAMPLES WERE PROVIDED. SAMPLE 1 INITIAL RESULT 132 MMOL/L, REPEAT 139 MMOL/L. SAMPLE 2 INITIAL 132 MMOL/L, REPEAT 142 MMOL/L. SAMPLE 3 INITIAL RESULT 134 MMOL/L, REPEAT 141 MMOL/L. SAMPLE 4 INITIAL RESULT 131 MMOL/L, REPEAT 138 MMOL/L. SAMPLE 5 INITIAL RESULT 128 MMOL/L, REPEAT 136 MMOL/L. INITIAL RESULT WERE REPORTED OUT. USER REPEATED TESTING ON OTHER ANALYZER AT THE SITE AND SENT OUT CORRECTED REPORTS. USER DID NOT BELIEVE THAT ANY OF THE PATIENTS WERE TREATED BASED ON THE LOW SODIUM RESULTS. SAMPLE 6 INITIAL RESULT 133 MMOL/L, REPEAT 137 MMOL/L, 139 MMOL/L, 138 MMOL/L AND 139 MMOL/L. SAMPLE 6 WAS A SPECIMEN THE USER WAS RUNNING ON SEVERAL INSTRUMENTS AS A DAILY CHECK. RESULTS FOR SAMPLE SIX WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A MISSING O-RING BETWEEN THE LITHIUM ELECTRODE AND SENSOR 2. HE REPLACED THE MISSING O-RING. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.