A field service engineer (fse) was at the customer site to address the reported event.Fse confirmed the complaint by reviewing the error logs and was not able to reproduce the error.Dl flags were found by the fse from the error logs and the syringe was identified not functioning properly which created a flow problem.Fse resolved the complaint by replacing the syringe.Fse repaired and validated the analyzer by successfully performing quality control run without error and within acceptable range.No further action required by field service.The aia-360 analyzer 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).From (b)(6) 2021 through aware date (b)(6) 2022.There were no similar complaints identified during the search period.The st aia-pack estradiol analyte application manual states the following: quality control in order to monitor and evaluate the precision of the analytical performance, it is recommended that commercially available control samples be assayed daily.The minimum recommendations for the frequency of running internal control material are: after calibration, two levels of controls are run in order to accept the calibration curve.The two levels of controls are also repeated after calibration when certain service procedures are performed (e.G.Temperature adjustment, sampling mechanism changes, maintenance of the wash probe or detector lamp adjustment or change).The most probable cause of the reported event was due to the faulty syringe.
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