(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On 17-jun-2015, fse arrived at the site to address the reported event.Fse replaced the defective prefilter housing.Next, he verified correct operation of the device.No further issues were noted.No further action was required by field service.The most probable cause of the reported event was due to leaking of the prefilter housing.
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On (b)(6) 2015, the customer reported that the prefilter housing was leaking with g8 analyzer.On (b)(4) 2015, a field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hba1c.There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
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