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

Model Number	PT-001788
Medical Device Problem Code	Problem with Software Installation (3013)
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364); Loss of consciousness (2418)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to the reported hospitalization and diabetic ketoacidosis.No lot release records were reviewed, as the product lot number was not provided.Locked down smartphone: lockdown.Omnipod software app version: 3.1.1.Smartphone operating system: sp1a.210812.016.G970usqu9ixe2.Smartphone hardware: sm-g970u.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.High blood glucose is a common symptom for people with diabetes (glucose monitoring data from people with diabetes indicate that on average, they can experience blood glucose levels above 250 mg/dl for 14-25% of the time[1][2][3].), and it would be challenging to speculate on a cause for the complaints without receiving the devices back for an engineering investigation.[1] beck rw, bergenstal rm, cheng p, kollman c, carlson al, johnson ml, rodbard d.The relationships between time in range, hyperglycemia metrics, and hba1c.J diabetes sci technol 2019;13:614-626 [1] welsh jb, derdzinski m, parker as, puhr s, jimenez a, walker t.Real-time sharing and following of continuous glucose monitoring data in youth.Diabetes ther 2019;10:751-755 [1] puhr s, derdzinski m, welsh jb, parker as, walker t, price da.Real-world hypoglycemia avoidance with a continuous glucose monitoring system's predictive low glucose alert.Diabetes technol ther 2019;21:155-158.
Event or Problem Description
It was reported that the patient had been hospitalized with diabetic ketoacidosis (dka).The patient was not able to log in to the omnipod 5 application on their phone.The patient's blood glucose level rose to 800 mg/dl, and they lost consciousness.The patient's son called an ambulance, and the patient was taken the hospital.At the hospital, the patient was treated with intravenous insulin and closely monitored their magnesium and potassium levels, and provided treatment based on those observations.The customer also informed us that they got occupational therapy (ot) and physical therapy (pt) once they were able to walk.The patient was discharged after 6 days.

• 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: 22187087
• Report Number: 3004464228-2025-25731
• Device Sequence Number: 20987030
• 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): 06/11/2025

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-001788
• Device Catalogue Number: M009-3P-AP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/11/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 53 YR
• Patient Sex: Female