Description of Event or Problem · 1
THE CUSTOMER RECEIVED AN ESTIMATED 50 QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) RESULTS FROM 7:00 PM ON (B)(6) 2012 UNTIL 8:00 AM ON (B)(6) 2012. MOST OF THE SAMPLES WERE TESTED IN CUPS FROM THE MODULAR PREANALYTIC (MPA) WITH THE EXCEPTION OF THE ER PATIENTS THAT WERE RUN IN THE PRIMARY TUBE. ALL SAMPLES THAT WERE INITIALLY TESTED DURING THAT TIME PERIOD WERE REPEATED FROM THE PRIMARY TUBE ON COBAS 8000 SERIAL NUMBER (B)(4). OF THE DATA PROVIDED FOR 61 PATIENT SAMPLES, THE RESULTS FOR THE FOLLOWING 51 PATIENT SAMPLES WERE DISCREPANT. ALL RESULTS ARE INITIAL FOLLOWED BY REPEAT AND ARE IN MMOL/L. PATIENT 1: SODIUM 165/154, CHLORIDE 129/117. PATIENT 2: SODIUM 149/141. PATIENT 3: SODIUM 147/139. PATIENT 4: SODIUM 150/140. PATIENT 5: SODIUM 148/141. PATIENT 6: SODIUM 147/138, CHLORIDE 110/99. PATIENT 7: SODIUM 154/144. PATIENT 8: SODIUM 151/140, CHLORIDE 112/101. PATIENT 9: CHLORIDE 105/117. PATIENT 10: SODIUM 148/140. PATIENT 11: SODIUM 148/140. PATIENT 12: SODIUM 149/141. PATIENT 13: SODIUM 143/133. PATIENT 14: SODIUM 126/133. PATIENT 15: SODIUM 154/146, CHLORIDE 115/104. PATIENT 16: SODIUM 150/141. PATIENT 17: SODIUM 144/137. PATIENT 18: SODIUM 147/140. PATIENT 19: SODIUM 151/141, CHLORIDE 116/104. PATIENT 20: SODIUM 147/137. PATIENT 21: SODIUM 149/143. PATIENT 22: SODIUM 148/140. PATIENT 23: SODIUM 151/142. PATIENT 24: SODIUM 150/144. PATIENT 25: SODIUM 149/141. PATIENT 26: SODIUM 148/141. PATIENT 27: SODIUM 151/142. PATIENT 28: SODIUM 152/142. PATIENT 29: SODIUM 153/144. PATIENT 30: SODIUM 150/140. PATIENT 31: SODIUM 132/143. PATIENT 32: SODIUM 147/139. PATIENT 33: SODIUM 150/144. PATIENT 34: SODIUM 140/149. PATIENT 35: SODIUM 150/141. PATIENT 36: SODIUM 152/143. PATIENT 37: SODIUM 150/143. PATIENT 38: SODIUM 145/134. PATIENT 39: SODIUM 146/137. PATIENT 40: SODIUM 153/144, CHLORIDE 117/106. PATIENT 41: SODIUM 151/143. PATIENT 42: SODIUM 150/142. PATIENT 43: SODIUM 152/141. PATIENT 44: SODIUM 154/142. PATIENT 45: SODIUM 130/141. PATIENT 46: SODIUM 153/144. PATIENT 47: SODIUM 152/146. PATIENT 48: SODIUM 152/139. PATIENT 49: SODIUM 153/147. PATIENT 50: SODIUM 148/140. PATIENT 51: SODIUM 147/140. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE CUSTOMER DID NOT KNOW IF THERE WAS AN ADVERSE EFFECT TO ANY OF THE PATIENTS. THE SODIUM ELECTRODE LOT NUMBERS WERE P62 WITH AN EXPIRATION DATE OF 03/31/2013 AND N39 WITH AN EXPIRATION DATE OF 12/31/2012. THE CHLORIDE ELECTRODE LOT NUMBER WAS B42 WITH AN EXPIRATION DATE OF 03/31/2013. THE CUSTOMER STATED SHE HAD HEARD THERE WAS A "DUST BUNNY" ON THE PROBE. THE PROBE WAS CLEANED AS PART OF DAILY MAINTENANCE ON (B)(6) 2012. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE AND NOTED THE CUSTOMER HAD PERFORMED CORRECTIVE MAINTENANCE PRIOR TO HIS ARRIVAL TO RESOLVE ISSUE. HE PERFORMED ISE CHECKS AND PRECISION TESTING WHICH MET SPECIFICATIONS.