MAUDE Adverse Event Report: INSULET OMNIPOD; INSULIN PUMP

Model Number OMNIPOD

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Date 11/08/2014

Event Type  Injury  

Event Description

My (b)(6) son received the omnipod insulin pump manufactured by insulet recently.On every third day or last day of wear, the insulin pod seemingly failed because his glucose levels increased to abnormally high levels.We informed insulet corporation of the problem and the company sent us a new omnipod replacement pdm device.However, on the first day of using the replacement omnipod pdm device on (b)(6), my son's glucose rose to 240 mg/dl on the first day, after one meal.This glucose value is atypical for him.The pod did not give any warning alarm to notify us of any insulin delivery problems.The humalog insulin that was inside of the pod was fresh and expires in 2017.My son continues to receive lantus as his basal insulin and he did not miss any lantus doses.We do not use the insulin pump or pod for his basal insulin delivery but only for his mealtime boluses.After this high glucose value, we instead gave him a traditional shot of humalog 1 unit via a pen shot and his glucose came down to a normal level or 116 mg/dl after 20 minutes.

• Brand Name: OMNIPOD
• Type of Device: INSULIN PUMP
• Manufacturer (Section D): INSULET
• MDR Report Key: 4253540
• MDR Text Key: 4992801
• Report Number: MW5039049
• Device Sequence Number: 1
• Product Code: LZG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 02/29/2016
• Device Model Number: OMNIPOD
• Device Catalogue Number: POD-ZXP425
• Device Lot Number: L41258
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 3 YR
• Patient Weight: 17