Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).A field service engineer (fse) was dispatched to the customer's facility to address the reported event.The fse found that adjusting the flow factor did not correct the reported issue.The fse verified the reported issue on site per the patient results.The pump pressure was unstable.The fse replaced the faulty pump assembly, set the flow factor (ff) to 1.08 ml/min and the retention time was 0.59 minutes.The fse verified precision, calibration, and quality control (qc).All results were within acceptable range.All errors cleared and the g8 instrument was operational.No further actions were required by field service.A (b)(6)-month complaint / service history review for similar complaints was performed for the serial number (b)(4) from aware date of (b)(6) 2018, which included data from (b)(6) 2017 through (b)(6) 2018.There were no similar complaints identified during the searched period, which includes this event.The g8 operator's manual under chapter 1, introduction and applications, states the following: the time from injection of the sample to the time the specific peak elutes off the column is called retention time.The tosoh automated glycohemoglobin analyzer hlc-723g8 software has been written so that each of the expected fractions has a window of acceptable retention times.If the designated peak falls within the expected window, the chromatogram peaks will be properly identified.When a peak elutes at a retention time not within a specified window, an unknown peak (p00) results.If more than one peak elutes at times not specified by the software windows, each is given a sequential p0x title.In order to keep the peaks within their appropriate windows, it may be necessary to change how fast or slow the buffers are moving through the system by changing the pump flow rate.The g8 variant analysis mode training manual under lesson 8 - troubleshooting, states the following: adjusting the flow rate - how and why on the tosoh automated glycohemoglobin analyzer hlc-723g8; variant analysis mode it may be necessary to adjust the flow rate because either unidentifiable peaks appear on all the chromatograms or the average retention time for various peaks has changed significantly.The flow rate is changed by changing the flow factor in the instrument.The flow factor is generally 1.00 ml/min.The flow factor should only be adjusted +/- 0.05 of the default factory setting.The most probable cause for the reported event was the pump failure.
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A customer reported p00 peaks on samples and quality controls (qc) on the g8 instrument.The customer stated that the retention times were running long, 0.63-0.65 minutes.The column count was 1500 injections, the filter was new, and the pump pressure was 8.2 mpa.Technical support (ts) advised the customer to adjust the flow rate from 1.24 ml/min to 1.28 ml/min.The customer wanted to continue to run so the flow rate was adjusted.The customer ran whole blood samples to check retention times, 0.58, 0.60, 0.62, 0.62, and 0.61 minutes.Ts advised the customer to recalibrate and to run qc.The customer is aware of the retention time range of 0.57-0.61 minutes.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for 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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