MAUDE Adverse Event Report: INSULET CORPORATION OMNIPOD INSULIN MANAGEMENT SYSTEM; PUMP, INFUSION, INSULIN

Model Number	19191
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the complainant the device will not be returned for investigation.We are unable to confirm the reported needle mechanism failure or to determine its root cause.Lot release records were reviewed and the product lot met all acceptance criteria.Locked down smartphone: data not available omnipod software app version: data not available operating system: data not available hardware: data not available cgm sensor type: data not available.Please note, the device identifiers are captured as reported by the complainant and may not align with the device configuration reported in this section as this data is pulled from our cloud based on the reported date of event.
Event or Problem Description
It was reported by the mother of a patient that the needle did not move forward when the pod was activated; this indicates a needle mechanism failure.The pod was not worn.No impact to the patient's glucose level was reported.

• Brand Name: OMNIPOD INSULIN MANAGEMENT SYSTEM
• Common Device Name: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer (Section G): INSULET CORPORATION; 100 nagog park; acton MA 01720
• Manufacturer Contact: derek heyl ; 100 nagog park; acton, MA 01720 ; 9786007000
• MDR Report Key: 25148415
• Report Number: 3014585508-2026-27430
• Device Sequence Number: 9397080
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)250904(17)270904(10)L71483
• Combination Product (Y/N): N
• PMA/510(K) Number: K211575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L71483
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/12/2026
• Date Device Manufactured: 09/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Male