(b)(4).On 14-mar-2018, a field service engineer (fse) verified customer's reported event at customer's site.The fse inspected instrument and found build up on the lead screw.Fse replaced the large syringe assembly to address the issue.The fse successfully completed quality control run within acceptable range.No further action was required by the fse.G8 instrument is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 14-feb-2017 through aware date 14-mar-2018.There were three (3) similar complaints identified during the searched period, which includes this event.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: 6.3 error messages when consulting with technical support about a problem, please note the error message and error number.In addition, if you follow the suggested solutions in this section and are still unable to resolve the error, or if you encounter an error message that is not noted, contact technical support.General error messages with these errors, the assay stops and the analyzer immediately enters stand-by state.706 syringe-l error is an operational error in syringe-l.Customer is instructed to inspect x1-axis and inspect syringe-l then execute smp.Reset.The most probable cause of the reported event was due to a faulty large syringe lead screw.
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On (b)(6) 2018, a customer reported getting 706 syringe-l error messages on the g8 instrument.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hemoglobin a1c (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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