MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 IOS APP

Model Number	PT-002343
Medical Device Problem Code	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cloud data for the period of 20oct2025-23oct2025 was downloaded for review.Review of the cloud data found that a 4 u bolus was started on the date of occurrence.The cloud data showed that the 4 u bolus was manually adjusted to 4 u and no carbs or blood glucose values were entered.The cloud data also shows a termination record for the 4 u bolus approximately 3 minutes after the start of the bolus.It could not be conclusively determined if the user attempted multiple times unsuccessfully to cancel this bolus before a successful attempt occurred.It also could not be conclusively determined if an attempt was made to enter 0.4 rather than 4, as the cloud data does not contain logging of the interactions with the controller.The exact cause of the reported event could not be determined.Cloud - locked down/smartphone lockdown cloud - omnipod 5 software app version 3.1.1 cloud - operating system n5004l-am-q-mv01602-06-01.06 cloud - hardware n5004l cloud - 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 reported that they accidentally programmed a bolus of 4 units instead of the intended 0.4 units.Upon quickly realizing the mistake, the patient tried to cancel the bolus.However, the patient reported that the bolus could not be canceled.No impact on the patient's glucose levels was reported.

• 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: 23617269
• Report Number: 3004464228-2025-57960
• Device Sequence Number: 8968667
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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-002343
• Device Catalogue Number: M009-2S-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/21/2025
• 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
• Patient Age: 63 YR
• Patient Sex: Female