MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD GO INSULIN DELIVERY DEVICE; INSULIN PUMP

Model Number	PT-000705-10
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Additional 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 customer's infusion site infection.No lot release records were reviewed, as the product lot number was not provided.
Event or Problem Description
It was reported that a pod, placed on the left upper thigh, was removed after 48 hours due to a pinching sensation that was noticed while walking.The pod site reaction measured to be approximately half-dollar in size, and appeared reddened, swollen, and was painful to touch.The patient's physician prescribed keflex (antibiotic), steroids, and was given a shot of toradol for pain/discomfort.The patient confirmed a dark spot is still present at the pod site, however the issue has been resolved, and further intervention is not expected.

• Brand Name: OMNIPOD GO INSULIN DELIVERY DEVICE
• Common Device Name: INSULIN PUMP
• 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: 18064637
• Report Number: 3004464228-2023-30923
• Device Sequence Number: 5936968
• Product Code: LZG
• UDI-Device Identifier: 10385084000106
• UDI-Public: (01)10385084000106
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K223372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: PT-000705-10
• Device Catalogue Number: POD-INS-I1-1025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown