MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD 5 APP; 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	11/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device data logs, and cloud data will not be available for investigation due to no patient information provided.This decimal point event can occur if a user programs their personal iphone settings to a region outside of the united states, as some regions use a comma instead of a period as a decimal separator character for numbers.The hardware settings in the patient's personal device were unable to be confirmed, therefore we are unable to confirm the root cause of the reported event.
Event or Problem Description
It was reported by an insulet patient that they are unable to enter a decimal point when programming a bolus in the omnipod 5 ios app being used on their iphone.The patient reported they are only able to enter a bolus in whole number units.The complaint information was received via an affiliate form from the ios app store, and no other information was provided.It is not possible to obtain additional information, as the patient was not identified.

• 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: 22087857
• Report Number: 3004464228-2025-22603
• Device Sequence Number: 6948118
• 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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 05/27/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• 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 Sex: Unknown