(b)(4).Device evaluation by manufacturer: field service engineering (fse) visited the customer to address the reported event.Fse confirmed the instrument was consistently getting error 102 for going over pressure limit, preventing any sample runs.Fse inspected the injector valve, and was able to isolate the issue to the i5 injector line, going from the t junction at the pump to the i5 port.Fse replaced the i5 injector line and that resolved the 102 error.Fse ran a precision run, and all 10 runs completed successfully within acceptable range and without any errors.No further action required by field service.The g8 instrument is functioning as expected.A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4).There were no similar complaints identified during the search period.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.102 pres limit over: the pump pressure has risen abnormally and has caused the shutdown circuit to be activated.Turn the main power switch off and remove the cause of the pressure increase.Refer to 100 pressure high.The most probable cause of the reported event was due to a clogged i5 injector line.
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A customer reported getting high pressure alarms on g8 instrument error 102 pressure over limit.The technical support specialist (tss) instructed the customer to change the filter, but high pressure alarm persisted.Tss instructed the customer to perform a pressure test with the filter removed, but pressure remained high.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay of 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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