Additional information provided in d.9., h.3., h.6.And h.10.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The returned sample was visually inspected and confirmed the probe associated with the pak was not returned by the customer.The root cause is unknown.As the customer did not return all components associated with this complaint sample, a full evaluation could not be performed.As described, it is important to remind the customer to return all products associated with the event for a full evaluation.No action will be taken for this occurrence, as the root cause is unknown.No adverse trends have been observed associated with the reported product and event.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.Consumables manufacturing has been made aware of this complaint.The manufacturer internal reference number is: (b)(4).
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