Description of Event or Problem · 1
EVENT OCCURRED IN 2006, BUT WAS CALLED INTO ROCHE ON 12/19/2006. TWO PT SAMPLES WHICH WERE RUN ONE BEHIND THE OTHER RECOVERED WITH ELEVATED RESULTS. PT ONE, INITIAL SODIUM RESULT OF 160 MMOL/L, POTASSIUM RESULT 6.9 MMOL/L, CALCIUM RESULT 8.8 MG/DL, AND BUN RESULT OF 35 MG/DL, INITIATED REPEATING THIS PT SAMPLE. THE FIRST PT'S RERUN RESULTS ARE AS FOLLOWS; SODIUM 136 MMOL/L, POTASSIUM 5.7 MMOL/L, CALCIUM 8.8 MG/DL AND BUN 27 MG/DL. SECOND PT'S INITIAL RESULT FOR SODIUM 143 MMOL/L, POTASSIUM 6.9 MMOL/L WAS REPEATED AND RECOVERED SODIUM 133 MMOL/L AND POTASSIUM 4.8 MMOL/L. ACCOUNT REPORTED THE PTS WERE TREATED USING THE INITIAL RESULTS. COULD NOT OBTAIN ANY MEDICAL HISTORY ON THESE PTS, NOR COULD OBTAIN ANY INFO ABOUT WHAT TYPE OF TREATMENT WAS GIVEN TO THE PTS OR THE OUTCOME BASED UPON STATED TREATMENT. DURING TROUBLESHOOTING, IT WAS DISCOVERED THE TIME FRAME FOR DEPROTEINIZING THE PROBES HAD ELAPSED. IN ADDITION THE CUSTOMER WAS INSTRUCTED IN HOW TO APPROPRIATELY PREPARE THE CALIBRATOR AND QC MATERIALS. BECAUSE THE EVENT OCCURRED IN 2006, THE ANALYZER PERFORMANCE COULD ONLY BE EVALUATED BASED UPON 12/19/2006 PERFORMANCE STATUS. QC MATERIALS WERE RUN AND PERFORMANCE EVALUATED ON 12/19/2006. BOTH LEVELS OF CONTROLS RECOVERED WITHIN MFR'S STATED RANGE.