Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 02/08/2017
Event Type
malfunction
Manufacturer Narrative
A field service engineer was dispatched who replaced the sample z axis assembly and performed a precision check.No further action required by field service.The most probable cause of the reported event was pn: xp035.(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).
Event Description
On (b)(6) 2017 a customer reported z axis assembly issue with their g8 analyzer.A field service engineer (fse) was dispatched on (b)(6) 2017 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.