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
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: (b)(6).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.
Event or Problem Description
It was reported that the patient faced an insulin flow blocked alarm event on (b)(6) 2026.Blood glucose level was high at the time of the event and patient took insulin pen to resolve the issue.

• 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: 24827312
• Report Number: 3003442380-2026-86161
• Device Sequence Number: 9187560
• 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