MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD; PUMP, INFUSION, INSULIN

Model Number POD-ZXP420

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Date 04/22/2019

Event Type  Injury  

Event Description

I tried switching to a new insulin pump, the omnipod.With each site, i developed large, red, and painful lumps where the cannula was inserted after only a few hours that got progressively worse in size and severity as i changed out the pod to a new one.I then developed blisters with the last pod i wore and had to immediately remove the pod and go back onto my old insulin pump from medtronic minimed.I still have painful, red lumps for over a week.I was on the omnipod for 11 days total before stopping because of these lumps.The blisters and pain are so bad i had to go to an urgent care, who unfortunately didn't understand what was happening and prescribed me meds i was not comfortable taking.I am still in immense pain and infection.My omnipod rep tried everything she could think of to help me, but none of it worked.She stated she and her colleagues had never seen any reaction like this before, especially with it occurring only a few hours after applying a new pod.Fda safety report id# (b)(4).

• Brand Name: OMNIPOD
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION
• MDR Report Key: 8555483
• MDR Text Key: 143386305
• Report Number: MW5086199
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): Y
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/10/2020
• Device Model Number: POD-ZXP420
• Device Lot Number: L44415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR