Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2016
Event Type
malfunction
Manufacturer Narrative
A field service engineer (fse) was dispatched who gave part number, customer ordered and installed new check valves, which resolved the issue.No further action required by fse.The probable cause of the event was check valve failure.(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 peak pattern issues 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.