MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 APP; ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP

Model Number	PT-002343
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Hypoglycemia (1912); Coma (2417)
Date of Event	07/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event was reported to insulet by dexcom, the family has not contacted insulet.Additional information is not available.Prior to the event, the patient had changed from using an insulet provided controller to her personal smartphone with the omnipod 5 app.A cloud log review yielded the omnipod 5 app operated as designed, no malfunction was identified.The settings programmed by the user into the app on thier smartphone did not align to the previously set device.This resulted in a higher than previously utilized basal rate delivery of insulin.Cloud - locked down/smartphone phone_control_ios.Cloud - omnipod 5 software app version 2.0.2.Cloud - operating system 18.3.Cloud - hardware iphone16.2.Cloud - cgm sensor type g6.*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
A partner complaint from dexcom reported that the patient inadvertently administered a bolus of 41 units of insulin, leading to hypoglycemia.The patient consumed food and believed their blood glucose levels were increasing.The patient was subsequently discovered unconscious, prompting a call to emergency medical services.At the time of this report, the patient was in a coma.

• Brand Name: OMNIPOD 5 APP
• Common Device Name: ALTERNATE CONTROLLER ENABLED INSULIN INFUSION 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: derek heyl ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 23599831
• Report Number: 3004464228-2025-57561
• Device Sequence Number: 16025220
• Product Code: QFG
• UDI-Device Identifier: 10385083000459
• UDI-Public: (01)10385083000459
• Combination Product (Y/N): N
• PMA/510(K) Number: K231826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: PT-002343
• Device Catalogue Number: M009-2S-AP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 30 YR
• Patient Sex: Female