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
Event or Problem Description
It was reported by an insulet patient that they are unable to enter a decimal point in the omnipod 5 app when programming a bolus.Patient reported they are only able to deliver a bolus in whole numbers.No other information is available.Complaint was reported via an affiliate form, therefore follow up for additional information is not possible, as the patient is unable to be identified.
Additional Manufacturer Narrative
A software defect was identified in version 1.2.2 of the omnipod 5 app.This defect introduced an error in the bolus calculator where the entry of a decimal separator (period/comma) is not recognized by the device in a defined sequence of events.This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the confirmation screen prior to starting the bolus.This device will not be returned, we are unable to determine relationship to capa-000082 due to no patient identifier or software version provided.
Additional Manufacturer Narrative
D4 product model# changed to pt-000664 h11 changed to according to the complainant the device will not be returned for investigation.We are unable to confirm the reported bolus calculator issue.No lot release records were reviewed, as the product lot number was not provided.It was reported the patient was using an ios smartphone, the software defect mentioned previously was associated with version 1.2.2 and specific to android devices only.
Additional Manufacturer Narrative
Correction: report reference number 3004464228-2025-12443-00; (b)(4) is a duplicate file of report reference number 3004464228-2025-22603-00; (b)(4).Please refer to report reference number 3004464228-2025-22603-00; (b)(4).D4: primary udi updated to (b)(4), and catalog number updated to m009-s-ap.

• 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: 21665793
• Report Number: 3004464228-2025-12443
• Device Sequence Number: 7661967
• 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,Followup,Followup
• Report Date (Section B): 06/02/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 03/26/2025; 06/02/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown