MAUDE Adverse Event Report: MEDTRONIC MINIMED COMFORT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MMT-383A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient faced an insulin flow blocked alarm event on 26-feb-2026.Blood glucose level was high at the time of the event and patient took insulin pen to resolve the issue.
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: poland.Based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 8021545, manufacturing site: 3003442380.

• Brand Name: COMFORT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• Manufacturer Contact: courtney smith ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; 6032470255
• MDR Report Key: 24826956
• Report Number: 3003442380-2026-86163
• Device Sequence Number: 10305569
• Product Code: FPA
• UDI-Device Identifier: 05705244019645
• UDI-Public: 05705244019645
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K162812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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
• Device Model Number: MMT-383A
• Device Lot Number: 6013578
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2025
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown