(b)(4).Device evaluation by manufacturer: field service engineering (fse) visited the customer to address to address the reported event.During servicing, fse reloaded the 5.23 software and the instrument was operating as expected.Fse also performed a periodic maintenance (pm) without any issues.The instrument was verified as operational.There was no further action required by fse.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 17-aug-2017 through aware date (b)(6) 2018.There were no similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 7 data management, states the following: the analyzer's system program and assay parameters are backed up by the internal battery.When a system program version has been upgraded or some problem has corrupted the system program, use the following procedure to reload the program and other data from the smart media socket.The most probable cause of the reported event was due to a facility's power outage that caused the software to be corrupted.
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