MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 ANDROID APP; OMNIPOD 5 APP

Model Number	PT-001788
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypoglycemia (1912); Visual Disturbances (2140); Dyskinesia (2363)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient was hospitalized in the intensive care unit with hypoglycemia.Blood glucose levels declined to 40 mg/dl while wearing a pod.Symptoms reported include difficulty ambulating, sweating, visual disturbances and heart palpitations.Patient reported hypoglycemia has been ongoing issue despite recently having settings adjusted per their physician to increase target blood glucose levels.It was also noted the patient had recently downloaded the omnipod 5 app, therefore resetting the adaptative basal feature.The patient was treated with glucose gel and intravenous fluids with dextrose.The patient remained in the hospital at time of reporting.
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.Locked down smartphone: phone_control_ios.Omnipod software app version: 2.0.2.Operating system: 18.3.Hardware: iphone14.2.Cgm sensor type: g6.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 ANDROID APP
• Common Device Name: OMNIPOD 5 APP
• 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: 22929936
• Report Number: 3004464228-2025-38915
• Device Sequence Number: 10231551
• Product Code: QFG
• UDI-Device Identifier: 10385083000565
• UDI-Public: (01)10385083000565
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 08/30/2025

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-001788
• Device Catalogue Number: M009-3P-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 09/02/2025
• 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: 56 YR
• Patient Sex: Female