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

Model Number	PT-001788
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The physical device was not returned for investigation.Cloud data was reviewed for the period of 17may2025 to 27may2025.The cloud data showed no evidence of the system delivering insulin while insulin delivery was suspended.The data showed that the system was only used in manual mode.Review of the algorithm/basal pulses delivered in each cycle in comparison to the basal rates captured in the data confirmed that the system was correctly delivering the user's manual basal program.Review of the insulin on board (iob) captured in the data confirmed the report that iob increased upon suspension of insulin delivery.Only the algorithm iob was observed to increase after suspension.The data showed no increase in the pod total pulse count during these suspension periods, confirming that the pods were not delivering insulin while insulin delivery was suspended.Due to how the system calculates algorithm iob, any changes in the manual basal program can result in changes in iob as the system compares the current basal rate to the adaptive basal rate to calculate iob.When insulin delivery is suspended, the drop in basal delivery in comparison to the adaptive basal rate causes iob to sharply increase though no insulin has been delivered.The iob was shown to decrease back to previous levels once insulin delivery was resumed.Review of the cloud data showed evidence that the system functioned as designed.Locked down smartphone: phone_control_android, omnipod software app version: 3.1.1, smartphone operating system: ap3a.240905.015.A2.S928usqu4byd9, smartphone hardware: sm-s928u, 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.
Event or Problem Description
The patient reported his omnipod system is delivering too much insulin resulting in hypoglycemia (levels unspecified).He reported pausing insulin delivery, and the system continued to deliver insulin.The customer felt insulin delivery continued while he had the system paused because his iob (insulin on board) increased after the system was paused.No other details were provided.If additional information is received, a supplemental report will be submitted.

• 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: 22302624
• Report Number: 3004464228-2025-27568
• Device Sequence Number: 4413634
• 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
• Report Date (Section B): 06/20/2025

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
• Device Lot Number: H000556
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 06/20/2025
• 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: 35 YR
• Patient Sex: Male