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

Model Number	PT-000559
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The case description states that the user reported that their dexcom blood glucose reading differed from a finger poke blood glucose reading.The user also reported seeing a 13u bolus was delivered at around 2:30pm, however the user stated that the last bolus they programmed occurred earlier in the day at around 11am-12pm and was only 4u.The physical controller was not received for investigation.Ios log files from the complaint device were uploaded to the cloud system by the user and downloaded for investigation.Investigation of the ios log files confirmed that on the date of occurrence, a 4u bolus was delivered followed by a 13u bolus.For the 13u bolus, the log files show that the application was brought to the foreground, the bolus button was pressed to open the bolus calculator, and a bg value from the user's cgm was loaded into the bolus calculator by pressing the use cgm button, which loaded a cgm value of 273 mg/dl.The logs then show that the total bolus volume was changed to 13u one digit at a time from 1 to 13, indicating manual adjustment of the total bolus amount.The confirm and start buttons were pressed to begin bolus delivery before the application was sent to the background again.The logs denote these interactions as user interactions with the application.Evidence of interaction with the application to program all boluses was observed in the log files.No evidence of an uncommanded bolus was observed in the available log files.No issues were observed in the ios log files that would contribute to incorrect dexcom sensor readings.The patient history buffer logs show that the system successfully received valid estimated glucose readings from the dexcom sensor, and the system responded appropriately to these sensor readings.The investigation could not determine the cause of the reported discrepancy in blood glucose readings between the dexcom sensor and a finger poke reading.Cloud - locked down/smartphone: phone_control_ios.Cloud - omnipod 5 software app version: 1.1.6.Cloud - smartphone operating system: 18.3.Cloud - smartphone hardware: iphone14.7.Cloud - cgm sensor type: g6.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 on (b)(6) 2025 he received an uncommanded bolus of 13 units from his omnipod 5 app (ios) resulting in hypoglycemia.The patient reported his dexcom cgm showed his glucose level to be 91 mg/dl and when he tested his blood glucose with a blood glucose meter, it was actually 44 mg/dl.He reported he could hear his pod clicking as it does when it delivers insulin.At the time the patient was reporting the issue to product support he had 7 units of iob (insulin on board).The screen showed the last bolus delivered was 13 units and was given around 2:30pm.The patient reported the last bolus he programmed and delivered was around 11am-12pm for lunch, and it was for 4 units.Symptoms and treatment information were not provided.The patient did not require any medical treatment.Data logs from the user were uploaded for investigation.

• 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: 22096196
• Report Number: 3004464228-2025-22806
• Device Sequence Number: 6906373
• 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): 05/28/2025

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: 05/01/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male