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 Codes	Purulent Discharge (1812); Erythema (1840); Itching Sensation (1943); Urticaria (2278); Skin Infection (4544); Skin Inflammation/ Irritation (4545)
Date of Event	02/01/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the complainant the device will not be returned for investigation.We are unable to determine if any product condition could have contributed to customer's infusion site infection and prescription reported.No lot release records were reviewed, as the product lot number was not provided.Locked down smartphone: no data available.Omnipod software app version: no data available.Operating system: no data available.Hardware: no data available.Cgm sensor type: no data 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 that the patient developed an infection at the pod¿s insertion site while wearing the pod.The patient reported the infusion site to be very red with blistering, itchiness, and drainage consisting of wound fluid, with no bleeding noted.Due to concern for infection and a known severe adhesive allergy, the patient removed the pod and sought medical attention from an internist.Upon examination, the internist cleaned the site with alcohol and diagnosed a skin infection associated with an adhesive reaction.The patient was prescribed oral antibiotics fluticason.For future pod use, the internist prescribed fluticasone spray to apply to the skin prior to pod placement to reduce allergic reactions.The patient reports this treatment has effectively prevented further infections, with only mild redness occurring if the spray layer is too thin.A new pod was placed.No further information was provided.

• 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: 25058440
• Report Number: 3014585508-2026-24948
• Device Sequence Number: 13118469
• Product Code: LZG
• UDI-Device Identifier: 20385081120033
• UDI-Public: (01)20385081120033
• 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): 05/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 19191
• Device Catalogue Number: ZXP425
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/01/2026
• 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: 43 YR
• Patient Sex: Female