MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 IOS APP

Model Number	PT-002343
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Unintended System Motion (1430)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cloud data for the period of (b)(6) 2025 was reviewed.Review of the cloud data showed that five 20 u boluses were delivered during this time period.The cloud data showed that two of the boluses were based on an entry of carbs and blood glucose values where the calculations were then adjusted to 20 u while the other three boluses had no inputs and were manually adjusted from 0 u to 20 u.The cloud data contains no further evidence of interaction with the controller in order to program, confirm, and deliver the 20 u boluses.We are unable to determine if any product condition could have contributed to the reported hospitalization and hypoglycemia.The physical device and/or user data logs were not provided.Without evidence of interaction with the controller, it could not be conclusively determined if these boluses were programmed by the user prior to delivery.The exact cause of the reported event could not be determined.If additional information is received, a supplemental report will be submitted.Locked down smartphone: not available.Omnipod software app version: not available.Operating system: not available.Hardware: not available.Cgm sensor type: not available.Please note, the device identifiers are captured as reported by the complainant and may not align with the device configuration reported in this section as this data is pulled from our cloud based on the reported date of event.
Event or Problem Description
It was reported the patient received 2 unprogrammed boluses of 20 units each, that resulted in hypoglycemia and hospitalization.

• 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: 23100958
• Report Number: 3004464228-2025-43093
• Device Sequence Number: 8618159
• 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): 09/19/2025

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: 08/20/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 15 YR
• Patient Sex: Female