Device evaluation by manufacturer: the aia-900, serial number (b)(4), was installed on (b)(6) 2019.A complaint history review and service history review for similar complaints was performed from installation date (b)(6) 2019 through aware date 16mar2020.There were no other similar complaints identified during the searched period.The st aia-pack fsh analyte application manual states the following: evaluation of results 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).After daily maintenance, at least two levels of the control should be run in order to verify the overall performance of the tosoh aia system analyzers.If one or more control sample value(s) is out of the acceptable range, it will be necessary to investigate the validity of the calibration curve before reporting patient results.Standard laboratory procedures should be followed in accordance with the regulatory agency under which the laboratory operates.The most probable cause of the reported event was due to biological contamination.
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The customer reported getting out of range low quality control (qc) results of the follicle stimulating hormone (fsh) on their aia-900 analyzer.Technical support specialist (tss) instructed the customer prepare a new set of controls, decontaminate the substrate line, then rerun the controls.Customer successfully completed the qc run within acceptable range.Customer also decontaminated the substrate line and recalibrated fsh without error.No further action required by tosoh.The aia-900 analyzer is functioning as expected.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
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