MAUDE Adverse Event Report: Insulet Corporation Omnipod 5 Controller; Alternate Controller Enabled Insulin Infusion Pump

Model Number	PT-000409
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hyperglycemia (1905); Abdominal Cramps (2543)
Date of Event	02/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had been hospitalized with diabetic ketoacidosis (dka) on february 1, 2026.The patient's blood glucose reached 600 mg/dl while wearing the pod between 24 and 36 hours.Symptoms reported include stomach pain and sugar not going down.The patient was treated with insulin (long acting and fast acting) for 12 hours.The patient was discharged after 12 hours.
Additional Manufacturer Narrative
The device has not been returned/received to date.If the device is received, a supplemental report will be submitted with the investigation results.We are unable to determine if any product condition could have contributed to the reported event.No lot release records were reviewed, as the product lot number was not provided.Locked down smartphone: data not available omnipod software app version: 3.1.1 operating system: n5004l-am-q-mv01602-06-01.06 hardware: n5004l 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 Controller
• 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 ; +1(978)600-7000
• MDR Report Key: 50933736
• Report Number: 3014585508-2026-71977
• Device Sequence Number: 10759799
• Product Code: QFG
• UDI-Device Identifier: 10385083000022
• UDI-Public: (01)10385083000022
• Combination Product (Y/N): N
• 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
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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-000409
• Device Catalogue Number: PDM-H001-G-XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/29/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male