A field service engineer was dispatched who fse replaced the small syringe, repeated 10 samples 3 times each with no error.The fse ran 2 patient samples that exhibited the error, and ran another 2 patient samples that experienced problems on the other instrument areas and on the second instrument, that was comparable to the first results, and all were within exceptable range.The most probable cause of the reported event was the vacuum in the tubes needs a special needle.(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).
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On (b)(6) 2017, a customer reported random high areas with their g8 analyzer.A field service engineer (fse) was dispatched on (b)(6) 2017 to address the reported event,which resulted in delay in reporting of patient results hba1c.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
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