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

Model Number	PT-001827
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In the case description, the user mentioned a 20 u bolus being delivered uncommanded.The physical controller was not received for investigation.Android log files from the complaint device were uploaded to the cloud system by the user and downloaded for investigation.Review of the android log files confirmed the delivery of a 20 u bolus.The audit log files showed that a 20 u bolus was confirmed and started based on no blood glucose or carb values entered.The engineering log files showed that the bolus button was pressed to open the bolus calculator.The logs show that the total bolus text was changed one digit at a time from 0 to 2 to 20 though no carbs or blood glucose values were entered.The confirm button was then pressed to bring the controller to the confirm bolus screen and then the start button was pressed to begin bolus delivery.The bolus record for the start bolus confirmed that a 20 u bolus was started and that the bolus was user adjusted from 0 u to 20 u.Review of the log files found evidence of interaction with the controller to program, confirm, and start the reported bolus.No evidence of an uncommanded bolus was observed in the available log files.Locked down smartphone: phone_control_android.Omnipod software app version: 3.1.1.Smartphone operating system: ap3a.240905.015.A2.G991usquehyda.Smartphone hardware: sm-g991u.Cgm sensor type: g6.Please note, that section d is capturing the device identifiers as reported by the complainant.This may not align to the device configuration reported in h11, as this data is pulled from our cloud based on the reported date of event.
Event or Problem Description
It was reported by the patient that they received an uncommanded bolus of 14.5 units of insulin on (b)(6) 2025.After reviewing the bolus history, the patient reported the uncommanded bolus was actually for 20 units, however his pod ran out of insulin and was only able to deliver 14.5 units.The bolus history showed bolus calculation for 0 carbohydrates, and no blood glucose level.Prior iob (insulin on board) showed 1.65 units, but no adjustments were made to the bolus amount for iob as a blood glucose level was not entered.The patient uses the omnipod 5 app, and reported his phone was in a pocket at the time of event and the app opened up on its own.The patient reported his last interaction with the omnipod app prior to the uncommanded bolus was around 12:30pm when he delivered a bolus for lunch.The uncommanded bolus was reported to have occurred at 3:54pm the same day.The patient noted he recently updated the software on his samsung galaxy s21, to android 15.The patient denied programming the bolus.The omnipod 5 app showed iob (insulin on board) of 7.54 units after the omnipod system had started to deliver the uncommanded bolus.The patient's max bolus is set to 20 units.Other omnipod 5 settings are target glucose of 120 mg/dl, corrective factor of 45 mg/dl, insulin to carbohydrate ratio of 1u to 7 grams or 1u to 11 grams, depending on the time of day, and duration of insulin action of 2.5 hours.No adverse events were reported due the uncommanded bolus.Patient did not require any medical attention or treatment.Data logs have been uploaded for lab investigation.

• 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: thom mcnamara ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 22127274
• Report Number: 3004464228-2025-23805
• Device Sequence Number: 8920732
• Product Code: QFG
• UDI-Device Identifier: 10385081120302
• UDI-Public: (01)10385081120302
• 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): 06/02/2025

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-001827
• Device Catalogue Number: PDM-H001-G-XX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2025
• Initial Report FDA Received Date: 06/02/2025
• 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
• Patient Age: 37 YR
• Patient Sex: Unknown