(b)(4).On (b)(6) 2016, an fse visited the customer to address the reported event.During servicing, fse confirmed the low pressure errors.Fse replaced the buffer valves, primed, washed, and ran several patient samples without any errors.The customer then ran controls and patient samples with acceptable results.The instrument was verified as operational.There was no further action required by fse.The most probable cause of the reported event was the buffer valves.
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On (b)(6) 2016, a customer reported low pressure with their g8 analyzer.The customer replaced the inline filter and the prefilter with no changes.They also performed a wash prime and drain flush but the low pressure persisted.The customer checked the buffer bags and verified that there were no leaks.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hga1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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