Additional information provided.As the customer did not retain the finished goods lot number, device history record (dhr) and lot history could not be reviewed.The cassette procedure pack was not returned, therefore, visual or functional testing could not be conducted in order to ascertain a potential failure mode of the consumable device.The root cause of the customer's complaint could not be established as a sample has not been received.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.After an investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and a root cause evaluation could not be performed.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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