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

Model Number 18320

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 12/03/2022

Event Type  Injury  

Event Description

It was reported the patient visited the dermatologist due to the skin developing a rash from using the pod.The dermatologist confirmed the patient had an allergic reaction to the plastic of the pod.

Manufacturer Narrative

The device has not been returned/received to date.If the device is received, a supplemental report will be submitted with the investigation results.We are unable to determine if any product condition could have contributed to the allergic reaction.No lot release records were reviewed, as the product lot number was not provided.

• 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: michael spears ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 16060881
• MDR Text Key: 306260625
• Report Number: 3004464228-2022-24638
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2022
• 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