(b)(4).Device evaluation by manufacturer: a (b)(6) complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018 there was one similar complaint identified during the searched period.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.In chapter 5- maintenance procedures, under daily checklist states: be sure to check the following items before starting analysis: (1) column, the maintenance schedule is 2500 tests; (2) filter, maintenance schedule if 400 tests.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 of the reported event was due to the flow factor adjustment.
|
On (b)(6) 2018, a customer reported getting fast retention time (rt) of 0.62 minute (the acceptable range is 0.57 to 0.61 minutes; optimal is 0.59 minute) on the g8 instrument.Technical support specialist (tss) advised the customer to adjust the flow factor to from 1.16 to 1.19, reboot the g8 instrument, and stabilize the flow rate.On (b)(6) 2018, tss followed-up with the customer for update to the reported event.The customer reported that the g8 instrument is performing as expected after the flow rate adjustment, the retention time is at the optimal 0.59 minute.All quality controls (qc) results are within acceptable range.The customer repeated one patient sample after the g8 was recalibrated and repeated; the result correlated as expected.It is not known whether hemoglobin a1c results were different before and after the retention time adjustment.There is no indication of any patient intervention or adverse health consequences due to this event.
|