(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).On 08-may-2017, fse arrived at the site to address the reported event.Fse corrected the error by performing preventative maintenance, which included replacing the large syringe tip and cleaning and lubricating.No further errors were reported.No further action was required by field service.The most probable cause of the reported event was due to fault/ failure of the large syringe binding.
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On (b)(6) 2017, the customer reported receiving a constant "706 l syringe" error with their g8 analyzer.Technical support (ts) advised the customer to replace the sample needle due to a possible obstruction; however, the issue did not resolve.On (b)(4) 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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