Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 08/07/2016
Event Type
malfunction
Manufacturer Narrative
A field service engineer was dispatched who conducted on-site follow-up with the customer.The fse observed that the valves were not clicking on and off so they were replaced.This returned the instrument to normal operation.The most probable cause of the reported event was due to defective valves.(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).
Event Description
On (b)(6) 2016, a customer reported low pressure with their g8 analyzer.A field service engineer (fse) was dispatched on (b)(6) 2016, 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.