(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2017, fse arrived at the site to address the reported event.Fse replaced the small syringe.The customer was subsequently able to run patient samples without issue.No further action was required by field service.Of note, the customer had previously been down for approximately one year, and recently had preventative maintenance of the device.The most probable cause of the reported event was due to fault/ failure of the small syringe.
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On (b)(6) 2017, the customer reported receiving low total area on patient samples with their g8 analyzer.On (b)(6) 2017, 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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