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

Model Number	PT-002343
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The case description states that the user received several 10u uncommanded boluses on (b)(6) 2025.Ios log files from the omnipod 5 application were uploaded to the cloud system by the user and downloaded for investigation.Inspection of the ios log files confirmed the delivery of the reported 10u boluses on the dates and reported times of occurrences.Evidence of interaction was observed to program, confirm, and begin delivery of all 10u boluses.The logs show that for each bolus, the bolus button was tapped to enter the bolus calculator.For three of the boluses, the carb entry field was modified one digit at a time to reach 100 grams.For all 10u boluses, a bg value from the user's cgm was loaded into the bolus calculator by pressing the use cgm button.Additionally, the logs indicate that each bolus volume was user-adjusted by modifying the total bolus field one digit at a time to reach 10u.The confirm and start buttons were pressed to begin bolus delivery.Review of the application log files confirmed evidence of interaction with the application to program all reported boluses.No evidence of an uncommanded bolus was observed in the available log files.Cloud - locked down/smartphone: phone_control_ios.Cloud - omnipod 5 software app version: 2.0.2.Cloud - operating system: 18.5.Cloud - hardware: iphone14.7.Cloud - 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.
Event or Problem Description
It was reported that the patient received multiple unprogrammed boluses from their omnipod 5 system resulting in hypoglycemia.Blood glucose levels declined into the lower 50 mg/dl range.No medical treatment was required for the reported issue.If additional information is received, a supplemental report will be submitted.

• Brand Name: OMNIPOD 5 IOS 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: 22668009
• Report Number: 3004464228-2025-34084
• Device Sequence Number: 15355383
• Product Code: QFG
• UDI-Device Identifier: 10385083000459
• UDI-Public: (01)10385083000459
• 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): 07/30/2025

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-002343
• Device Catalogue Number: M009-2S-AP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Sex: Female