Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 02/18/2016
Event Type
malfunction
Manufacturer Narrative
A field service engineer was conducted follow-up with the customer over the phone to address the reported event.Fse performed troubleshooting with the customer and determined there was a clogged line at the bottom of the prefilter after removing the i-5 & i-6 lines.The customer unclogged the line and the device pressure and controls returned to normal.She was able to successfully run patient samples without issue.No further action was required by field service.The most probable cause of the reported event was due to a clog in the i-6 line near the prefilter.(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).
Event Description
On (b)(6) 2016, the customer reported high pressure errors with their g8 analyzer.A field service engineer (fse) was dispatched on (b)(6) 2016, the customer to address the reported event,which resulted in delay in reporting of patient results hba1c.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.