(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2017, fse conducted follow-up with the customer over-the-phone to address the reported event.Fse assisted the customer to disassemble the prefilter housing, then instructed her to reseat the connections.There were no more reports of high pressure errors.No further action was required by field service.The most probable cause of the reported event was due to an obstruction in the prefilter tubing.
|
On (b)(6) 2017, the customer reported high pressure with their g8 analyzer.The customer attempted to troubleshoot by changing the column and filter; however, the issue persisted.Technical support (ts) instructed the customer to remove the filter tubing and check the pressure.Pressure was noted to be 7-8 mega pascals (mpa).On (b)(6) 2017 field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
|