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

Model Number	PT-000559
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the patient that when a bolus is programmed in the omnipod 5 app for android, only about half of the bolus is delivered.The patient reported they have typically been able to control their blood glucose levels well; however, they were recently diagnosed with fatty liver disease, and prescribed medication.They are now seeing blood glucose readings of 400 mg/dl while wearing the pod.No symptoms associated with hyperglycemia were provided.The patient also reported receiving low blood glucose alerts in the app when her blood glucose is not low (127 mg/dl).No medical attention was required.The patient uploaded their data logs for investigation.
Additional Manufacturer Narrative
The case description states that the user is receiving incorrect low blood glucose (bg) alerts.It also states the user reported the device is only delivering half of the programmed boluses.The physical controller was not received for investigation.Android log files from the complaint device were uploaded to the cloud system by the user and downloaded for investigation.Investigation of the android log files found the user programmed and delivered a 5 unit and 1.7 unit bolus on the date of occurrence.The log files show both boluses were fully delivered and completed with 0 units remaining.It is also shown that the pulse count increased accordingly with the boluses, indicating the entire bolus volume was delivered.The system was found to function as intended.No hazard alarms or alerts regarding a low bg were observed on the date of occurrence in the log files.Locked down smartphone: phone_control_android, omnipod software app version: 3.1.1, smartphone operating system: up1a.231005.007.S921usqs4ayb3, smartphone hardware: sm-s921u, cgm sensor type: g7.*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.

• 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: 22043403
• Report Number: 3004464228-2025-21618
• Device Sequence Number: 8908574
• 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): 05/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PT-000559
• Device Catalogue Number: M009-P-AP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 05/19/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown