MAUDE Adverse Event Report: ANIMAS CORPORATION ONETOUCHPING GLUCOSEMGMTSYSTEM; INSULIN INFUSION PUMP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Hyperglycemia (1905); Hypoglycemia (1912); Nausea (1970); Respiratory Distress (2045); Vomiting (2144)

Event Type  Death  

Event Description

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.

Manufacturer Narrative

The pump has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.

• Brand Name: ONETOUCHPING GLUCOSEMGMTSYSTEM
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 342
• Manufacturer (Section G): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 342
• Manufacturer Contact: kelly stone ; 200 lawrence dr; west chester, PA 19380-3428 ; 4089564746
• MDR Report Key: 3726845
• MDR Text Key: 18811416
• Report Number: 2531779-2014-08821
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-MCBC-64
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 1 MO
• Date Manufacturer Received: 03/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 40 YR