Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2017
Event Type
malfunction
Manufacturer Narrative
A field service engineer was dispatched who replaced the needle wash block.The g8 was functioning as intended.No further actions required from field service.The most probable cause of the reported event was the screws were stripped out of the needle wash block.(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 that the needle wash block screws were stripped out on 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.