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

Model Number	19191
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient's blood glucose level rose to 28 mmol/l (504 mg/dl) while wearing the pod for an unknown duration.The device was originally reported for pod customer not sure delivering insulin.Investigation of the device found a tear in the exposed portion of the cannula and the tip of the needle to be dull.
Additional Manufacturer Narrative
Investigation of the returned device found a tear in the exposed portion of the soft cannula that contributed to the reported event.The observed soft cannula damage is currently under the referenced capa investigation.No further post market investigation is required.Inspection of the cannula subassembly found the tip of the formed needle to be squared-off and dull.This inadequate formed needle tip did not contribute to the reported event.The observed external cannula tear is related to action # 9056196-05/20/2026-002-c.

• 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: 25556356
• Report Number: 3014585508-2026-37028
• Device Sequence Number: 18640882
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033(11)240927(17)260927(10)L72510
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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 Expiration Date: 09/27/2026
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Device Lot Number: L72510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 9056196-05/20/2026-002-C
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Sex: Female