MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 IOS APP

Model Number	PT-002343
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	09/25/2025
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 the reported hospitalization and diabetic ketoacidosis.No lot release records were reviewed, as the product lot number was not provided.
Event or Problem Description
It was reported that the patient had been hospitalized with diabetic ketoacidosis (dka).The patient experienced trouble connecting to the phone due to storage issue.The system was in manual mode prior to dka.Treatment, blood glucose level, time pod was worn, symptoms, and length of hospital admission were not reported.Three attempts were made to follow up but they were unsuccessful therefore information is limited.

• Brand Name: OMNIPOD 5 IOS APP
• Common Device Name: OMNIPOD 5 IOS APP
• 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: 23381024
• Report Number: 3004464228-2025-50467
• Device Sequence Number: 9091372
• Product Code: QFG
• UDI-Device Identifier: 10385083000459
• UDI-Public: (01)10385083000459
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K231826
• 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): 10/24/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PT-002343
• Device Catalogue Number: M009-2S-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/24/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 17 YR
• Patient Sex: Female