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

Model Number	PT-001788
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device and/or user data logs were not returned and/or uploaded for investigation.We are unable to confirm the reported uncommanded boluses or to determine the root cause.No lot release records were reviewed, as the product lot number was not provided.Locked down smartphone: phone_control_android.Omnipod software app version: 3.1.1.Smartphone operating system: ap3a.240905.015.A2.S911usqs6dydb.Smartphone hardware: sm-s911u.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
The patient's daughter reported after a software update on the patient's android smartphone, the omnipod system has been delivering boluses not programmed by the user.No impact on the patient's blood glucose level was reported.The patient did not require medical attention related to the alleged event.If additional information is received, a supplemental report will be submitted.

• Brand Name: OMNIPOD 5 ANDROID 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: thom mcnamara ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 22484500
• Report Number: 3004464228-2025-30796
• Device Sequence Number: 15592131
• Product Code: QFG
• UDI-Device Identifier: 10385083000565
• UDI-Public: 10385083000565
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K203768
• 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): 07/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 06/13/2025
• Initial Report FDA Received Date: 07/11/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male