Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 06/28/2016
Event Type
malfunction
Manufacturer Narrative
A field service engineer was dispatched who conducted on-site follow-up with the customer and found that the instrument would lose pressure when it switched to buffer #1.The fse changed the buffer #1 valve which returned the instrument to normal operation.The most probable cause of the reported event was due to a sticking valve.(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 on their g8 analyzer.A field service engineer (fse) was dispatched on (b)(4) 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.