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

Model Number	PT-000664
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Hypoglycemia (1912); Convulsion/Seizure (4406)
Date of Event	05/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In the case description, the user mentioned that a fingerstick blood glucose reading did not match the blood glucose values on the omnipod 5 application and so the user was not alerted to their blood glucose levels being urgently low.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.Review of the ios log files confirmed that the pod did not receive blood glucose values low enough to trigger the generation of an urgent low glucose alert on the date of occurrence.The patient history buffer (phb) audit data showed that the automated algorithm was able to appropriately adapt the microbolus amounts based on the estimated glucose values and user inputs.The automated algorithm appropriately reduced and stopped the automated delivery of insulin as the blood glucose values received by the pod decreased and reached lower values.The phb data confirmed that the pod did receive blood glucose values in the 60-80 mg/dl range on the date of occurrence, however the pod stopped delivering microboluses several cycles before this range was reached.It cannot be confirmed if the sensor was generating incorrect blood glucose values and sending them to the pod.The exact cause of the reported blood glucose value discrepancy could not be determined.Cloud - locked down/smartphone phone_control_ios.Cloud - omnipod 5 software app version 1.1.6.Cloud - smartphone operating system 18.4.Cloud - smartphone hardware iphone15.2.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 while driving he experienced a seizure due to hypoglycemia with a subsequent visit to the er (emergency room).Patient stated he did not receive an urgent/critical low glucose alarm indicating his glucose levels were below 60 mg/dl from the omnipod system due to his cgm (continuous glucose monitor) reporting his glucose levels to be in the 80 mg/dl range.However, when the patient arrived at the er, his actual blood glucose when tested with a blood glucose meter was 40 mg/dl.The pod was worn between 24 and 36 hours in the arm.The patient's wife treated the hypoglycemia by putting a source of glucose under his tongue.At the er, the patient was treated with additional glucose, water, peanut butter, and crackers.The patient was released the same day once his blood glucose levels had stabilized.User data logs were uploaded for investigation.

• 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: 22294177
• Report Number: 3004464228-2025-27437
• Device Sequence Number: 8467538
• Product Code: QFG
• UDI-Device Identifier: 10385083000336
• UDI-Public: 10385083000336
• 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): 06/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: PT-000664
• Device Catalogue Number: M009-S-AP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male