Device evaluation by manufacturer: a field service engineer (fse) found the filter was possibly clogged and the filter housing was very tight on the filter, restricting flow.The fse checked the fluidic lines and column, installed a new filter, and g8 analyzer operated without any error messages.The fse then proceeded to run quality controls and patient samples, which passed.The g8 analyzer was working in accordance to the manufacturer's expectations; no further action was required.A 13-month complaint and service history review was performed on serial number (b)(4) for similar complaints from 25-aug-2016 through aware date (b)(4) 2017.No other similar complaints were identified during the searched period.G8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: error messages: when consulting with technical support about a problem, please note the error message and error number.In addition, if you follow the suggested solutions in this section and are still unable to resolve the error, or if you encounter an error message that is not noted, contact technical support.General error messages: with these errors, the assay stops and the analyzer immediately enters stand-by state.100 pressure high: the pump pressure exceeded the upper limit (15 mpa) set in the pres high parameters.When the filter or column replacement period has been exceeded, first replace the filter or column.If the pressure is still high, remove the inlet and outlet flow line around the column and filter, and determine which part is the cause of the high pressure.Then, contact a technical support representative.If the pressure displayed on the screen is: (a) greater than the pressure on the column inspection report + 4 mpa, then replace the filter.(b) less than the pressure on the column inspection report, then proceed with priming the column.The most probable cause of the reported event was due to a clogged filter.This report is being submitted due to an internal nonconformance identified.(b)(4).
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