The reporter contacted animas on (b)(4)2014 indicating that the patient passed away on (b)(6) 2014.The reporter stated that they do not know if the pump caused or contributed to the patient¿s death.The reporter said that the patient was a medtronic pumper for about three years prior to receiving the animas pump and received the one touch ping (otp) on (b)(6) 2014.The reporter stated that the patient was asked to send back the medtronic pump.Allegedly the patient did not want to be without a pump, watched the video, read the owner¿s booklet, and started began use of the otp prior to training.The patient stated that the patient was using the pump for several weeks with no issues except occasional low blood glucose (bg) which was successfully self-treated.The reporter stated that occasional hypoglycemia was not unusual for the patient.The reporter stated that prior to the patient¿s death, on (b)(6) 2014, the patient went four-wheeling with no apparent health or diabetes issues.On (b)(6) 2014, the patient woke up feeling sick and spent the day vomiting.Bg was reported to be over 600mg/dl.The patient did not eat anything all day and refused to contact a healthcare professional (hcp).The patient stopped vomiting that evening and was given ginger-ale to prevent dehydration.The reporter stated that they do not know when th infusion set was last changed refilled a new cartridge on (b)(6) 2014.The reporter does not have any information as to when the patient last delivered a bolus as the patient handled the pump and treatment independently.On the morning of (b)(6) 2014 the patient appeared to be having trouble breathing, 911 was called and patient was taken to the hospital.The reporter stated that the patient coded twice on the way to the hospital.The insulin pump was removed in the emergency room.The reporter stated that they worked on the patient for several hours and treated the patient with iv insulin.The reporter does not have details about any other bg readings, the admitting diagnosis, or any other treatment the patient received.This complaint is being reported because the insulin pump could not be ruled out as a cause or contributor in the patient¿s death.
|