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

Model Number	PT-001662
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
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 hypoglycemia.Lot release records were reviewed, and the product lot met all acceptance criteria.Specifically, a pod is paired to a pdm and put through simulated use testing including communicating with the pdm, deployment, delivering fluid, occlusion detection, and freedom from hazard alarms.Cloud - locked down/smartphone: data not available.Cloud - omnipod 5 software app version: data not available.Cloud - smartphone operating system: data not available.Cloud - smartphone hardware: data not available.Cloud - 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.
Event or Problem Description
According to the reporter, the patient visited the emergency room on (b)(6) 2025.The patient's blood glucose levels decreased to less than 54 mg/dl.The patient reported needing to remove the pod due to a memory corruption error on the omnipod 5 iphone app.The patient then relied on backup treatment and did not resume treatment on the pods.The patient was in the er at the time of the complaint.At this time there is insufficient information to determine if insulet's device caused or contributed to the reported event.Additional information has been solicited, and a supplementary report will be filed if received.

• 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: 23979688
• Report Number: 3014585508-2026-00620
• Device Sequence Number: 11900698
• Product Code: QFG
• UDI-Device Identifier: 10385081120302
• UDI-Public: (01)10385081120302(11)250429(17)261029(10)PH1U04292542
• 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): 01/06/2026

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-001662
• Device Catalogue Number: POD-OMNI-I1-6720
• Device Lot Number: PH1U04292542
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 01/06/2026
• Date Device Manufactured: 04/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 30 YR
• Patient Sex: Female