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

Model Number	MMT-368A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient city: (b)(6).Patient country: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.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 infusion set tape was not sticking on (b)(6) 2026.

• 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: pamela meadows ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; 3367062840
• MDR Report Key: 24769383
• Report Number: 3003442380-2026-89463
• Device Sequence Number: 9267153
• Product Code: FPA
• UDI-Device Identifier: 05705244019492
• UDI-Public: 05705244019492
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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
• Device Model Number: MMT-368A
• Device Lot Number: 6013491
• 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: 03/06/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2025
• 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