MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 IOS APP

Model Number	PT-000664
Medical Device Problem Codes	Use of Device Problem (1670); Reset Problem (3019)
Health Effect - Clinical Codes	Fatigue (1849); Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Chills (2191); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	05/02/2026
Type of Reportable Event	Serious Injury
Additional 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 reported event.Lot records were not reviewed because the suspect product is the iphone application.Locked down smartphone: data not available.Omnipod software app version: 2.1.0.Operating system: 26.3.Hardware: iphone17.1.Cgm sensor type: data 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 that the patient had been hospitalized with diabetic ketoacidosis (dka) on (b)(6) 2026.The patient¿s iphone omnipod application got reset and they lost all their controller settings.They were unable to set up a new pod because the settings were missing.The patient's nurse sent their settings to them, but they didn¿t understand them and was delayed entering settings and the following day she needed to go to the hospital.The patient's blood glucose levels reached greater than 400 mg/dl while wearing the pod an unspecified number of hours.Symptoms reported include hyperglycemia, chills, ¿heart was beating really fast¿, nausea, vomiting, weakness, and fatigue.She spent two days in the intensive care unit and received unspecified treatment for dka.The patient was discharged from the hospital on (b)(6) 2026.

• 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: derek heyl ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 25488484
• Report Number: 3014585508-2026-35138
• Device Sequence Number: 9966317
• Product Code: QFG
• UDI-Device Identifier: 10385083000336
• UDI-Public: (01)10385083000336
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

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-000664
• Device Catalogue Number: M009-S-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 06/12/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 57 YR
• Patient Sex: Unknown