ISE INDIRECT NA-K-CL FOR GEN.2

Additional Manufacturer Narrative

CALIBRATION WAS LAST PERFORMED ON THE DAY OF THE EVENT. THE ALARM TRACE SHOWED MULTIPLE ABNORMAL ASPIRATION ALARMS AROUND THE TIME OF THE EVENT. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT AN INTERNAL STANDARD BOTTLE HAD BEEN LOADED INTO THE DILUENT BOTTLE POSITION ON THE ANALYZER. THE FSE REPLACED THE BOTTLE AND THE SYRINGE SEALS, PRIMED THE SYSTEM, AND PERFORMED CALIBRATION AND QC SUCCESSFULLY. THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE USER ERROR. THE SERVICE MAINTENANCE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ISE INDIRECT NA-K-CL FOR GEN.2 (CL), POTASSIUM ELECTRODE (K), AND SODIUM ELECTRODE (NA) RESULTS FOR 5 PATIENT SAMPLES ON A COBAS 8000 COBAS ISE MODULE. THIS MEDWATCH WILL COVER CL. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE K RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE NA RESULTS. THE CUSTOMER HAD NOTICED AN INCREASED FREQUENCY OF HIGH RESULTS WHICH PROMPTED THEM TO REPEAT PATIENT SAMPLES. FOR SAMPLE 1, THE INITIAL NA RESULT WAS 167 MMOL/L, THE INITIAL K RESULT WAS 5.2 MMOL/L, AND THE INITIAL CL RESULT WAS 123 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE NA RESULT WAS 141 MMOL/L, THE K RESULT WAS 4.5 MMOL/L, AND THE CL RESULT WAS 108 MMOL/L. FOR SAMPLE 2, THE INITIAL NA RESULT WAS 244 MMOL/L AND THE INITIAL K RESULT WAS 7.8 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER. THE NA RESULT WAS 140 MMOL/L AND THE K RESULT WAS 4.1 MMOL/L. FOR SAMPLE 3, THE INITIAL NA RESULT WAS 220 MMOL/L, THE INITIAL K RESULT WAS 8.4 MMOL/L, AND THE INITIAL CL RESULT WAS 166 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE NA RESULT WAS 131 MMOL/L, THE K RESULT WAS 5.3 MMOL/L, AND THE CL RESULT WAS 100 MMOL/L. FOR SAMPLE 4, THE INITIAL NA RESULT WAS 183 MMOL/L, THE INITIAL K RESULT WAS 86.3 MMOL/L, AND THE INITIAL CL RESULT WAS 137 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE NA RESULT WAS 138 MMOL/L, THE K RESULT WAS 4.7 MMOL/L, AND THE CL RESULT WAS 104 MMOL/L. CLARIFICATION ON IF THE INITIAL K RESULT WAS ACCURATE WAS REQUESTED BUT COULD NOT BE CONFIRMED. FOR SAMPLE 5, THE INITIAL NA RESULT WAS 208 MMOL/L, THE INITIAL K RESULT WAS 6.0 MMOL/L, AND THE INITIAL CL RESULT WAS 156 MMOL/L. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND THE NA RESULT WAS 143 MMOL/L, THE K RESULT WAS 3.8 MMOL/L, AND THE CL RESULT WAS 108 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE DEEMED CORRECT.

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER IS (B)(6) THE QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.