On (b)(6) 2016, the customer reported a high pressure error with their g8 analyzer.The customer attempted to troubleshoot by replacing the filter; then, they ran quality control (qc) and thirty-seven patient samples.The high pressure alarm sounded again.Next, the customer performed pressure tests.Further inspection of the device revealed a leak coming from the drain flush handle which closed at 3 o'clock.On (b)(6) 2016, a 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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