(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).On 17-mar-2017, fse arrived at the site to address the reported event.Fse replaced the sample loop, ran whole blood, then quality control (qc).Next, he instructed the customer to recalibrate and rerun controls.No further issues were reported and no further action was required by field service.The most probable cause of the reported event was due to fault/ failure of the sample loop.
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On (b)(6) 2017, the customer reported high pressure with their g8 analyzer.They changed the filter in an effort to troubleshoot but now the device had no pressure.The customer, then attempted a drain flush with no resolution.After inspecting the device, he found that "the second valve down was leaking".He attempted to tighten the tubing but the leak persisted.On (b)(4) 2017 field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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