(b)(4).Device evaluation by manufacturer: a field service engineering (fse) visited the customer to address the reported event.Fse verified the high pressure problem by observing the high pressure alarm.Fse replaced the line six of high pressure system.The customer successfully validated instrument by running quality controls (qc) and patient samples.The pressure was running at 8.56 mpa and holding steady.The g8 instrument was working as expected.No further action was required by the fse.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4).There were no similar complaints identified during the search period.The g8 variant analysis mode operator's manual under chapter 2, pre-installation, states the following: 6-9 mpa is the ideal pressure, however, every instrument is slightly different and the combination of different columns with different instruments may sometimes show a slightly higher or lower pressure than the ideal 6-9mpa.Some judgment may be necessary.On the column inspection report is a pressure specification, i.E., 5.1 mpa.If the pressure displayed on the screen is: greater than the pressure on the column inspection report + 4 mpa, then replace the filter.Less than the pressure on the column inspection report, then proceed with priming the column.The most probable cause of the reported event is pending investigation completion.
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A customer reported getting a high pressure of 11.3mpa with the g8 instrument.The customer reported that an acceptable pressure range was 6.9-10.9 mpa.The customer replaced the filter but pressure reading remained the same.Technical support specialist (tss) instructed customer to power off and back on, but pressure was still unchanged.The column count was 579.Tss instructed customer to perform pressure tests.Customer performed test in the following parameters.Test performed with the filter: pressure = 3.78 mpa.Test performed with the filter off of the right side of the column: pressure = 3.89mpa.Test performed with the filter off of the left side of the column: pressure = 11.4mpa.The tss asked the customer to change the column, and pressure test was then performed again.Test performed with filters on: pressure = 12.8 mpa.Test performed with filter off of the left side of the column: pressure = 12.6 mpa.Tss determined the column was working fine and not the cause of the high pressure.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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Additional manufacturer narrative: tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.Device evaluation by manufacturer: the i6 peek line was returned to tosoh instrument service center (isc) for investigation.Functional testing confirmed the blocked i6 peek line.Parts will be discarded.The most probable cause of the reported event was due to a blockage in i6 peek line.
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