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

Model Number	PT-000664
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Hypoglycemia (1912); Speech Disorder (4415)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cloud - locked down/smartphone phone_control_ios cloud - omnipod 5 software app version 1.1.6 cloud - smartphone operating system 17.6 cloud - smartphone hardware iphone12.1 cloud - cgm sensor type g6 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 hospitalization and hypoglycemia.No lot release records were reviewed, as the product lot number was not provided.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.
Event or Problem Description
The patient reported that on (b)(6) 2025, she was taken to the hospital by ambulance because she experienced hypoglycemia that dropped to less than 54 mg/dl while using her controller in manual mode, which continued to pump insulin despite her dropping blood glucose levels.The omnipod system has to be in automated mode in order to pause insulin delivery if the cgm (continuous glucose monitor) is relaying readings of 55 mg/dl or less.The patient reported her hypoglycemia resulted in her losing the ability to speak for 7 hours.She called an ambulance and was taken to the hospital.The patient stated that she was unable to log into her controller, prompting her to switch to an iphone (which is not compatible with her g7 pods) and stay in manual mode, which she believes caused her hospitalization.She was aware that in manual mode the pump has to be paused by the user but stated she had always relied on the closed-loop system in automated mode.Her blood glucose level was recorded as low, and she treated it by calling an ambulance.The pod was worn between 4 and 24 hours on the arm.

• 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: 22145127
• Report Number: 3004464228-2025-24358
• Device Sequence Number: 15301280
• Product Code: QFG
• UDI-Device Identifier: 10385081120302
• UDI-Public: (01)10385081120302
• 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): 06/04/2025

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-000664
• Device Catalogue Number: M009-S-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 06/04/2025
• 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: 29 YR
• Patient Sex: Female