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

Model Number	PT-001788
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Headache (1880); Hyperglycemia (1905)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, the patient was admitted to the emergency room due to hyperglycemia, with blood glucose levels reached 700 mg/dl.The incident occurred while wearing the pod on the abdomen between 4 and 24 hours.The patient stated she removed the pod at home prior to being transported to the emergency room.The patient was unable to administer insulin because the associated app was not functioning, and no backup method was available.In addition to hyperglycemia, the patient had a headache and emergency services were called.The patient required oxygen in the ambulance and was treated with insulin.At the time of report, the patient had not yet been discharged from the hospital.
Additional Manufacturer Narrative
According to the complainant, the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to the reported hospitalization and hyperglycemia.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: tp1a.220624.014.G996usqs5dwa5.Smartphone hardware: sm-g996u.Cgm sensor type: g7.*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.

• 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: 22204592
• Report Number: 3004464228-2025-26254
• Device Sequence Number: 20761772
• 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): 06/13/2025

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?: No
• 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: 05/23/2025
• Initial Report FDA Received Date: 06/13/2025
• 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: 77 YR
• Patient Sex: Female