(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).This report is being submitted due to a retrospective review conducted under capa(b)(4).On (b)(6) 2017, an fse conducted an onsite follow-up with the customer to address the reported event.During servicing, the fse replaced the tube for the line filter and replaced the old prefilter.After these changes, the pump ran with good results.The pressure returned to normal.Fse also performed calibration and ran controls.The instrument was verified to be operating as expected.There was no further action required by fse.The most probable cause of the reported event was clogged prefilter.
|
On (b)(6) 2017, a customer reported they were getting high pressures with their g8 analyzer.Technical support advised the customer to change the filter.However, the next day, the customer reported that they replaced both the column and the filter but observed a cracked black nut/ferrule.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting a1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
|