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

Model Number	PT-000664
Medical Device Problem Code	Application Program Problem: Medication Error (3198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the patient that the bolus calculator is not recognizing the decimal on their omnipod 5 ios app.The patient gave an example that if bolus amount is programmed for 1.1 units, the app changes it to 11 units.The event occurred due to the user set the device's region within the phone's settings (not the op5 ios app) to south africa, which utilizes a comma instead of a period as the decimal separator character for numbers.When the user tries to press on the decimal character (comma), nothing is entered into the calculator.No adverse event occurred and medical treatment was required as a result of the event.
Additional Manufacturer Narrative
The event occurred due to the user set the device's region within the phone's settings (not the op5 ios app) to south africa, which utilizes a comma instead of a period as the decimal separator character for numbers.When the user tries to press on the decimal character (comma), nothing is entered into the calculator.Capa-000183 has been opened to document the investigation, and field action res96945 has been implemented.No further post market lab investigation evaluation is required.Locked down smartphone: phone_control_ios.Omnipod software app version: 1.1.6.Smartphone operating system: 18.4.Smartphone hardware: iphone11.8.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.

• Brand Name: OMNIPOD 5 IOS APPLICATION
• 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: 22087792
• Report Number: 3004464228-2025-22599
• Device Sequence Number: 6947553
• 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: 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): 05/27/2025

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-000664
• Device Catalogue Number: M009-S-AP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES96945
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Female