Description of Event or Problem · 1
THE CUSTOMER ALLEGED APPROXIMATELY 12 QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM RESULTS ON THE COBAS 6000 C501 MODULE. THE CUSTOMER STATED THE ISSUE HAD BEEN ONGOING SINCE (B)(6) 2010. THE CUSTOMER COULD ONLY PROVIDE COMPARISONS FOR 6 SAMPLES, 5 OF WHICH WERE DISCREPANT. FOR SAMPLE 1 THE INITIAL SODIUM AS 116 MMOL/L. THE REPEAT SODIUM, ON THE SAME ANALYZER, WAS 126 MMOL/L. FOR SAMPLE 2 THE INITIAL SODIUM AS 131 MMOL/L. THE REPEAT SODIUM, ON THE SAME ANALYZER, WAS 140 MMOL/L. FOR SAMPLE 3 THE INITIAL SODIUM AS 128 MMOL/L. THE REPEAT SODIUM, ON THE SAME ANALYZER, WAS 137 MMOL/L. FOR SAMPLE 4 THE INITIAL SODIUM AS 131 MMOL/L. THE REPEAT SODIUM, ON THE SAME ANALYZER, WAS 141 MMOL/L. FOR SAMPLE 5 THE INITIAL SODIUM AS 139 MMOL/L. THE REPEAT SODIUM, ON THE SAME ANALYZER, WAS 147 MMOL/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO PATIENTS WERE ADVERSELY AFFECTED BY THE EVENT. THE CUSTOMER DID NOT PROVIDE THE SODIUM ELECTRODE LOT NUMBER. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE EVENT WAS CAUSED BY A FLUIDICS FAILURE DUE TO DEFECTIVE ISE SIPPER SYRINGE SEALS. HE REPLACED THE SEALS. THE CUSTOMER PERFORMED CALIBRATION, QUALITY CONTROLS, AND PRECISION TESTING, WHICH WERE ACCEPTABLE.