(b)(4).On (b)(6) 2018, a field service engineer (fse) was dispatched to the customer's facility to address the reported event.Fse confirmed error 100 pressure high on the g8 instrument.Fse replaced the peek tubing at i-6 due to the peek tubing having a clog/obstruction.Fse also conducted a pre-scheduled preventive maintenance (pm) and ran calibration and quality controls (qc).All results passed within acceptable range.The g8 instrument was performing as intended.No further action was required from field service.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 operator's manual under chapter 6 - troubleshooting, provides guidance on error 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 obstruction in peek tubing.
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On (b)(6) 2018, customer reported getting error 100 pressure high on the g8 instrument.On (b)(6) 2018, 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 was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
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