(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).On 29-mar-2017, fse arrived at the site to address the reported event.First, fse verified the high pressure.Next, he replaced the obstructed peek tubing.Afterwards, pressure was 9.9 mega pascals (mpa) with the column at 2700 injections.Fse installed a newer colum and the pressure decreased to 8.55 mpa.No further issues were reported and no further action was required by field service.The most probable cause of the reported event was due to a clog in the l-6 line.
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On (b)(6) 2017, the customer reported receiving high pressure with their g8 analyzer.The customer replaced the column and filter with no resolution.The customer also performed a pressure test on the device.On (b)(4) 2017, a field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for 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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