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

Model Number 18320

Device Problem Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Itching Sensation (1943); Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 03/30/2023

Event Type  Injury  

Manufacturer Narrative

According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to the skin irritation.No lot release records were reviewed, as the product lot number was not provided.

Event Description

It was reported that a skin irritation and itching as well as bruising and a rash occurred from the pods adhesive while wearing the pod.The patient went to their doctor where they were prescribed cortisone cream and a second medication to control itching at the pod infusion site.The patients doctor advised the customer to use manual insulin and discontinue using the pod.

• Brand Name: OMNIPOD DASH INSULIN MANAGEMENT SYSTEM
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer (Section G): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer Contact: thom mcnamara ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 16812477
• MDR Text Key: 313985322
• Report Number: 3004464228-2023-10622
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385082000020
• UDI-Public: (01)20385082000020(17)000101(10)UNAVAILABLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211575
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 18320
• Device Catalogue Number: BLE-I1-529
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female