(b)(4).The device involved in this complaint has not been received by the manufacturer for evaluation at the time of this report.Verification of failure mode reported in the current manufacturing process was conducted.Thirteen device samples were taken from the current production.The samples were functionally inspected, and during testing, the issue reported was not observed in the current manufacturing process.A device history record investigation did not show issues related to this complaint.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determine the root cause.Corrective actions cannot be established at this time.If the device sample becomes available at a later date, this report will be updated accordingly.
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