This is the second complaint reported for this finished goods lot and the first reported for this issue.Review of the device history record indicates the order was built to specification.The customer did not retain a sample for this complaint report; therefore, visual inspection or functional testing could not be conducted.The root cause of the customer's complaint could not be established as a sample has not been received.Without a 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.No action will be taken for this occurrence, as the root cause is unknown and a sample was not returned.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).
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