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.
Event Description
The customer¿s mother reported via phone call that they were hospitalized due to high blood glucose and diabetic ketoacidosis on (b)(6) 218.Customer also reported that cannula was bent.The customer was treated with insulin pump.The insulin pump will not be returned for analysis.