Currently, it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We, therefore, consider this report complete to the best of our knowledge.(b)(4).
|
The customer reported via phone call of issues with high blood glucose levels.The customer's blood glucose level at the time of incident was unknown, but had been as high as 400mg/dl.The customer's most current level was 312mg/dl.The customer treated the highs with the pump and manual injections.Troubleshoot was conducted.The customer was advised to change entire set, reservoir and insulin.The customer was advised to monitor the device.
|