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

Model Number	PT-001788
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User initiated logs were not uploaded for investigation.We are unable to determine if any product condition could have contributed to the reported hypoglycemia.We are unable to confirm the reported uncommanded bolus or to determine its root cause.No lot release records were reviewed, as the product lot number was not provided.Cloud - locked down/smartphone phone_control_android cloud - omnipod 5 software app version 3.1.1 cloud - smartphone operating system sp1a.210812.016.G970usqu9ixe1 cloud - smartphone hardware sm-g970u 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 the omnipod system delivered an unprogrammed bolus that resulted in hypoglycemia.Blood glucose levels declined to 48 mg/dl while wearing the pod.No symptoms associated with hypoglycemia were reported.The patient treated her hypoglycemia with a snickers bar.No medical attention related to this event was required.No additional information was provided.Due diligence attempts were made to gather additional information; however, no new information was received.If additional information is received at a later date, a supplemental report will be submitted.
Additional Manufacturer Narrative
Cloud data for the day of (b)(6) 2025 was reviewed.The cloud data showed that the only bolus delivered on (b)(6) 2025 was a bolus of 2 u.The data shows that the user¿s insulin on board (iob) did reach over 9 u on (b)(6) 2025, however this was due to a sharp increase in the algorithm component of the iob.The data showed that the user was in manual mode and their basal program was running a rate of 140 pulses/hour (7u/hour) on the morning of (b)(6) 2025, which is significantly higher than their automated adaptive basal rate based on the total daily insulin of 34 u per day.This high manual basal rate caused the high iob due to how the algorithm iob is calculated.The system functioned as intended and no evidence of unexpected insulin delivery or uncommanded boluses was observed.

• 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: 22289844
• Report Number: 3004464228-2025-27392
• Device Sequence Number: 8467394
• Product Code: QFG
• UDI-Device Identifier: 10385083000565
• UDI-Public: 10385083000565
• 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,Followup
• Report Date (Section B): 08/06/2025

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-001788
• Device Catalogue Number: M009-3P-AP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 08/06/2025
• 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: 52 YR
• Patient Sex: Female