MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 ANDROID APP; OMNIPOD 5 APP

Model Number	PT-001788
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	11/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cloud data for the period of (b)(6) 2025 was downloaded and reviewed.Review of the data found a change in controller serial number on (b)(6) 2025, indicating a new controller start-up.The data showed that this new controller was set-up with a basal program of 6 u per hour for 24 hours.The basal program from the previous controller was found to be significantly lower than this.For the first pod used after setting up a new controller, the total daily insulin (tdi), which sets the adaptive basal rate, is based on the user input basal program.This 6 u per hour rate resulted in a tdi of 150 u per day, which resulted in a high adaptive basal rate.The patient history buffer data showed that the adaptive algorithm was able to appropriately adjust the microbolus amounts based on the tdi and the estimated glucose values received by the pod from the sensor.Due to the high tdi, these microbolus amounts were larger than those from the last pod used on the previous controller.The algorithm appropriately reduced and stopped automated insulin delivery as estimated glucose values decreases towards and below the user's target.No instances of the automated algorithm delivering automated insulin while estimated glucose values were below 60 mg/dl were observed.While in manual mode, the system was correctly delivering the user's manual basal program of 6 u per hour.The pod was changed on 03nov2025 and the tdi lowered to 44 u per day based on the previous pod.No evidence of issues with the system were observed in the available data.Locked down smartphone: phone_control_android omnipod software app version: 3.1.1 operating system: bp2a.250605.031.A3.S721usqu7cyi6 hardware: sm-s721u cgm sensor type: g7.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 hypoglycemia on (b)(6) 2025.The patient's blood glucose levels dropped to 23 mg/dl after wearing the pod for more than 48 hours.Their spouse discovered the patient unconscious, prompting a call to emergency medical services.The patient received treatment with a saline solution and "some kind of solution to raise her blood sugar." on the day of the incident, the patient indicated that insulin delivery had been paused for most of the time, yet their basal history indicated that more than twice the usual amount of insulin had been administered compared to other days.Additionally, it was noted that the patient had a virus on their phone, which led the phone store to delete and reinstall the omnipod 5 application while addressing the virus issue.The patient stated that no settings were configured in the application after it was reinstalled.Two days later, on (b)(6) 2025, the patient was discharged from the hospital, and the pod was disposed of there.

• Brand Name: OMNIPOD 5 ANDROID APP
• Common Device Name: OMNIPOD 5 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: 23716376
• Report Number: 3004464228-2025-60585
• Device Sequence Number: 13362536
• Product Code: QFG
• UDI-Device Identifier: 10385083000565
• UDI-Public: (01)10385083000565
• 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): 12/04/2025

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-001788
• Device Catalogue Number: M009-3P-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female