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

Model Number	PT-002343
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418); Convulsion/Seizure (4406)
Date of Event	10/27/2025
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 hospitalisation and hypoglycaemia.No lot release records were reviewed.Locked down smartphone: phone_control_ios omnipod software app version: 2.0.4 operating system: 26.0 hardware: iphone16.1 cgm sensor type: g7.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 had been hospitalised with hypoglycaemia on (b)(6) 2025.They reported that they had not been counting their carbohydrates accurately.The glucose level declined to approximately 20 mg/dl.Symptoms reported include loss of consciousness and seizures.The patient did not recall what treatment they received other than having a ct scan and electrocardiogram.The patient was released after two days.The pod was discarded.

• Brand Name: OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM
• 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: 23705679
• Report Number: 3004464228-2025-60299
• Device Sequence Number: 10673415
• Product Code: QFG
• UDI-Device Identifier: 10385083000459
• UDI-Public: (01)10385083000459
• 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): 12/03/2025

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-002343
• Device Catalogue Number: M009-2S-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 12/03/2025
• 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: 58 YR
• Patient Sex: Male