MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 IOS APP

Model Number	PT-002343
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A batch of user-initiated ios log files uploaded on 11jul2025 from a controller registered to the user was reviewed.The log files confirmed that a pod was activated at 10:30 on 21jun2025 and was discarded at 13:50 on 21jun2025.The patient history buffer data from the log files showed that the pod ran for 425 pulses, delivering 18.45 u of insulin, before deactivation.Review of the logs showed that the system delivered insulin as intended.The automated algorithm appropriately adapted the microbolus amounts based on the estimated glucose values received by the pod.No evidence of unexpected boluses was seen in the logs.The system was determined to function as intended and no evidence of an overdelivery of insulin was observed.Locked down smartphone: phone_control_ios.Omnipod software app version: 2.0.2.Operating system: 18.4.Hardware: iphone14.7.Cgm sensor type: g6.*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 received an unprogrammed bolus.The patient's mother reported hearing the pod beeping, and the omnipod 5 app showed the pod was empty.It was reported the pod had been filled with 200 units of insulin 3.5 to 4 hours prior to the event.Emergency medical services was called and the patient was transported to the emergency room.The patient was treated with juice.The patient was discharged from the er after 4 hours.The blood glucose level was were reported to be 300 mg/dl after treatment.If additional information is received, a supplemental report will be submitted.

• 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: thom mcnamara ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 22754170
• Report Number: 3004464228-2025-35614
• Device Sequence Number: 9558172
• Product Code: QFG
• UDI-Device Identifier: 10385083000459
• UDI-Public: (01)10385083000459(11)250214(17)260814(10)PH1U02142531
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 08/08/2025

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-002343
• Device Catalogue Number: M009-2S-AP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 11 YR
• Patient Sex: Male