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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Burning Sensation (2146)

Event Date 06/05/2020

Event Type  Injury  

Event Description

R abdominal pain, blistering which began (b)(6) 2020.The causative agent was thought to be started after omnipod dash device placed 24 hours prior, with novolog, and 9-10 pm.An associated sign and symptom is started itching and when she scratched, the liquid leaked from under the device, was a clear fluid, without odor, removed the device, and it looked like a popped blister and someone had taken the top layer of skin off and started burning after.The patient denies the following: f/s/c.Still itching and burning if exposed to air, or rubbed.Hydrogen peroxide that night and has been using soap and water and keeping the area clean since that time.Has used another device malfunction since the initial visit, with another omnipod dash device.Fda safety report id#: (b)(4).

• Brand Name: OMNIPOD DASH
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; acton MA 01720
• MDR Report Key: 10206025
• MDR Text Key: 196943867
• Report Number: MW5095255
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 85