Additional manufacturer narrative: (b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).Device evaluation by manufacturer: on (b)(6) 2018, a field service engineer (fse) was at customer's site to resolve reported issue.Fse confirmed customer's reported issue of high pressure.Fse also found clogged tubing from injection valve to prefilter housing.Fse replaced tubing and confirmed proper functioning of instrument.The g8 was performing within manufacturer's specifications; no further action was required by the fse.A 13-month complaint history review and service history review for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018 for similar complaints was performed.There were no similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: 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: greater than the pressure on the column inspection report + 4 mpa, then replace the filter.Less than the pressure on the column inspection report, then proceed with priming the column.The most probable cause of the reported event is due to failed tubing from injection valve to prefilter.
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On (b)(6) 2018, a customer reported getting high pressure on the g8 instrument.The customer stated the quality control (qc) was in acceptable range.The technical support specialist (tss) obtained several pressure readings from customer and all connections seemed to be secured, which lead tss to think there was a clog.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
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