Manufacturer evaluation of the instrument logs did not identify any instance involving failure to drain the cleaning alcohol on (b)(6) 2016, as reported by the complainant.However, two (2) instances indicating insufficient reagent in bottle 6 (80/20 ethanol/ipa) and one (1) instance indicating insufficient wax in wax chamber 1 were recorded in the instrument logs on 14 december 2016.The instrument functioned as designed in each of these instances by substituting the bottle or wax chamber containing insufficient reagent with reagent or wax from a suitable alternative station.There are 687 instances in which an event code indicating insufficient reagent has been recorded in the instrument logs in the period between (b)(6) 2016; and there are 243 instances indicating that a bottle containing either a processing or cleaning reagent was not in contact with the corresponding sensor for less than 20 seconds, which is not sufficient time to complete manual replacement of the reagent; and the properties of the corresponding reagent station were reset in the period between (b)(6) 2016.Resetting a reagent station sets the concentration to the default value configured in the reagent types definition unless an alternative value is entered into the instrument software by the user; and resets the number of cassettes processed and the number of cycles and days to zero.The root cause of these events being recorded in the instrument logs are use errors involving failure to follow the manufacturer instructions related to both the fill level required for reagent bottles and wax chambers as detailed in section 2.2.2 of the leica peloris/peloris ll user manual and the manual reagent replacement procedure as detailed in section 5.4.4 of the leica peloris/peloris ll user manual.Although the complainant did not report any adverse impact on the quality of tissue processing, it is considered that the malfunction involving incorrect completion of the manual reagent replacement process would either cause or contribute to a serious injury upon recurrence because this use error has previously caused serious injury.
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