Device evaluation by manufacturer: on (b)(4) 2018, a field service engineer (fse) followed-up over-the-phone and instructed the customer to disconnect the sample needle assembly and perform a drain flush; no errors were generated.The customer replaced the sample needle assembly as well.No further action was required by the fse.G8 instrument was functioning as designed.A (b)(4) complaint history review and service history review for similar complaints was performed for serial number (b)(6) from (b)(6) 2016 through aware date (b)(4) 2018.There were no similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: the 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.The 706 syringe-l error: explanation: operation error in syringe-l.Countermeasure: inspect x1-axis.Inspect syringe-l.Execute smp.Reset.Chapter 5, maintenance procedures, under section 5.10 provides step-by-step instructions on the sampling needle assembly replacement.The most probable cause of the reported event was due to a clogged sampling needle assembly.(b)(6).
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On (b)(6) 2018, a customer reported getting 706 syringe-l error messages with the g8 instrument.The customer reported hearing a grinding sound coming from the left side of the instrument.The technical support specialist instructed the customer to remove the center black cover and perform a sample reset.The customer stated that the sample needle assembly moved correctly until it went down the diluent or wash well; the grinding sound is generated and the instrument stops.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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