(b)(4).Actual device not evaluated.Process evaluation was not performed as the complaint is not related to product performance or packaging.No testing methods performed.Results: no results available since no evaluation performed.Conclusions: human factors issue.Training deficiency.Device not returned.Since this complaint is not related to product performance and the device will not be evaluated, this submission is considered a final report.Accriva diagnostics has requested all data required for form 3500a.
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