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

Model Number 19191

Device Problem Insufficient Information (3190)

Patient Problem Cyst(s) (1800)

Event Date 11/03/2020

Event Type  Injury  

Manufacturer Narrative

The device has been received and is pending an investigation.

Event Description

It was reported that a patient had sensitive skin and developed a cyst after using the omni pod.The cyst was the size of a grape.Patient thinks that the insulin was piling up under the skin and causing the issue.Patient went to the doctor and they did a biopsy to see what the lump was.It was negative for an infection.Patient tried switching the insulin type to see if this would fix the issue.

Manufacturer Narrative

The received device had the cannula assembly deployed and returned an 0x6a alarm.No evidence was found that would result in skin irritation occurring at the infusion site; a root cause for the reported event could not be determined.No other defects or deficiencies were found that would result in a failure of the device to deliver insulin; a root cause for the occlusion alarm could not be determined.

• Brand Name: OMNIPOD INSULIN MANAGEMENT SYSTEM
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• MDR Report Key: 10856377
• MDR Text Key: 216953148
• Report Number: 3004464228-2020-17897
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)200325(17)210925(10)L45662
• Combination Product (y/n): N
• PMA/PMN Number: K192659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/25/2021
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L45662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR