(b)(4).Device evaluation by manufacturer: a field service engineer (fse) contacted the customer over the phone to address the reported event.During troubleshooting, the customer informed fse that they had set the flow factor to 1.57 ml/min, which increased the pump pressure.This is what caused the leak.The customer adjusted the flow factor back to 1.12 ml/min and the pressure went back to normal.The instrument was working as expected.No further action was required by the fse.A 13-month complaint history review and service history review on g8 serial number (b)(4) from 12-nov-2017 through (b)(6) 2018.There were three similar reported issues, including this event, found during the searched period.The g8 operator's manual under chapter 3, assay operations, section 7, states the following: other items to check: check the flow line connections, particularly the filter and the column inlet and outlet for leaks during warming up operations.Tighten the connection if a leak is found.The g8 variant analysis mode training manual under lesson 8 - troubleshooting, states the following: adjusting the flow rate - how and why: on the tosoh automated glycohemoglobin analyzer hlc-723g8; variant analysis mode it may be necessary to adjust the flow rate because either unidentifiable peaks appear on all the chromatograms or the average retention time for various peaks has changed significantly.The flow rate is changed by changing the flow factor in the instrument.The flow factor is generally 1.00 ml/min.The flow factor should only be adjusted +/- 0.05 of the default factory setting.The most probable cause of the reported issue was due to incorrect flow factor setting by the customer which lead to increased pump pressure and the reported leak.
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