Additional information is provided in sections d.9, h.3, h.6 and h.11.The company representative was able to replicate the reported event.The fluidics module was replaced to address the issue.The system was tested and found to meet product specifications.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.The root cause of the reported event is attributed to nonconforming fluidics module.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Similar incident/event data was collected for the associated reported events.Quality assurance will continue to perform periodic monitoring for evidence of adverse trending and take further action as appropriate.The manufacturer internal reference number is: (b)(4).
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