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
Additional Manufacturer Narrative
Initial and final mdr (b)(4)- device 2 of 2 e1:patient city: (b)(6) patient country: canada.
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
Supplemental report 01 - (b)(4) - mdr 8021545-2025-00873.The initial mdr with manufacturing report number (8021545-2025-00873), was submitted on 29-apr-2025.Upon completion of the investigation, the manufacturing date was updated as 13-mar-2024.Additional information - this mdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary - complaint investigation results: a complaint investigation has been initiated under complaint investigation child record (b)(4).The batch 6005783.In question was manufactured at the osted site.Device history record (dhr) review: the 6005783 was manufactured according to the work instruction (wi) [79] appendix 1 batchcard for production of packaging room on 13-mar-2024 with a total of (b)(4) units.Review of the dhr showed that all relevant tests required during the related processes had been fulfilled and met the requirements.No deviation was identified, nor maintenance events were recorded related to complaint code.Test results: no product was returned.Conclusion summary of complaint investigation: as a result of the following, no non-conformance (nc) raised during production related to complaint code, no trend identified for the lot in question, no further actions are required.This complaint will not require further root cause investigation nor corrective and preventive action (capa) plan.Therefore, this issue will be monitored through the post market surveillance activities.
Event or Problem Description
To date no additional patient or event details have been received.

• 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: 21931913
• Report Number: 8021545-2025-00873
• Device Sequence Number: 8651328
• 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): 10/24/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 11/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• 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