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

Model Number	PT-000435
Medical Device Problem Code	Problem with Software Installation (3013)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was transported by the emergency medical services (ems) to the emergency room with hypoglycemia.The patient's blood glucose levels declined to around 20 mg/dl while wearing the pod for an unknown duration.The patient tried deleting and reinstalling the pod's application since they were having trouble activating a new pod.They were not able to login to their account, leading them to switch to manual insulin injections but resulted them into having blood glucose level to decline.The patient was treated with nasal glucagon and dextrose.The patient was discharged on the same day.The patient removed the pod prior to the emergency room visit.
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 emergency room visit and hypoglycemia.No lot release records were reviewed, as the product lot number was not provided.Locked down smartphone: data not available.Omnipod software app version: 2.1.0.Operating system: 26.2.Hardware: iphone12.8.Cgm sensor type: data not available.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.

• 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: derek heyl ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 24490377
• Report Number: 3014585508-2026-11190
• Device Sequence Number: 5091932
• Product Code: QFG
• UDI-Device Identifier: 10385081120302
• UDI-Public: (01)10385081120302
• Combination Product (Y/N): N
• 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): 03/02/2026

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-000435
• Device Catalogue Number: POD-BLE-H1-520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/02/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male