A field service engineering (fse) followed up with the customer over the phone to address reported event.Fse instructed the customer on proper decontamination procedures.The customer completed decontamination of the analyzer which resolved the issue.The customer successfully completed fsh control run without error and within acceptable range and confirmed the analyzer was operating as expected.No further action required by field service.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number (b)(4).There were three (3) similar complaints identified during the searched period, which includes this event.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 of the system.
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