MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC EXTENDED; UNO EWIS BLUE 60/6 HCAP 3-PK INT

Model Number	MMT-431AH
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in canada.It was reported that the patient faced insulin flow blocked alarm event on 1-apr-2025.The blockage was in the tubing.The patient replaced the infusion set and resumed insulin deliveries successfully.No further information available.
Additional Manufacturer Narrative
Initial and final mdr (b)(4) - mdr.E1: patient city: (b)(6).Patient country: canada.
Additional Manufacturer Narrative
Supplemental report 01 - (b)(4) - mdr 8021545-2025-00871.Additional information - this mdr is being submitted to include the below: d9: device available for evaluation has been selected as yes & date returned to mfg was added as well.H6: investigation results under type of investigation, investigation findings, investigation conclusions.
Event or Problem Description
To date, additional patient or event details were received which have been added in h11.

• Brand Name: MEDTRONIC EXTENDED
• Common Device Name: UNO EWIS BLUE 60/6 HCAP 3-PK INT
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 21931910
• Report Number: 8021545-2025-00871
• Device Sequence Number: 8742963
• Product Code: FPA
• UDI-Device Identifier: 05705244023161
• UDI-Public: 05705244023161
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: 02/01/2026
• Device Model Number: MMT-431AH
• Device Lot Number: 6005783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown