(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2016, a field service engineer (fse) was dispatched to the customer's facility to address the reported event.The fse found the sample needle was incorrectly installed.The mounting plate was not holding the needle in place and the needle was floating and not able to pierce the cap to pick up the sample.The fse re-installed the needle correctly, performed daily maintenance, and ran controls.The g8 instrument is operational.No further action is required by field service.The most probable cause of the reported event was the incorrect installation of the sample needle.
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On (b)(6) 2016, a customer reported broken sample probe with the g8 analyzer.The probe was bent.Technical support advised the customer on how to change the needle.The customer also stated the back well was overflowing.The customer is unable to run hba1c patient samples.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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