MAUDE Adverse Event Report: UNOMEDICAL A/S INSET GUARD; 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	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	10/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: canada.Since no lot number is available, a detailed investigation, tests on reference samples or batch review cannot be conducted.Therefore, this complaint will be closed, this issue will be monitored through pms product trends and malfunction.If any trends picked up, this will flag on the trips and alerts according to the omqr procedure.
Event or Problem Description
Reference number (b)(4).Event occurred in canada.It was reported that the patient went to an emergency room (er) and eventually got hospitalized on (b)(6) 2025 due to diabetic ketoacidosis (dka) event.Blood glucose level was 20.6 mmol/l at the time of the event and got treated with insulin via intravenous (iv).No further information available.
Additional Manufacturer Narrative
Unomedical hereby submits this supplemental report as part of its complaint remediation activities conducted under a capa/fda action plan.This submission includes a retrospective reassessment of previously evaluated complaints.Unomedical is providing this supplemental information in accordance with the reporting requirements set forth in 21 cfr part 803.Any fields left blank indicate that the information is unknown, unavailable, or remains unchanged.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: review of complaint record data base (b)(4) event description and all available information was completed and no lot number specific information identified.Requests for lot specific information were sent to the customer but were unable to be provided.As a result, an investigation was completed at the product family level medtronic extended and malfunction type occlusion issue.See attachment medtronic extended occlusion complaint closure investigation for more information.Corrective and preventive action (capa) plan determination: based on the available information, no further investigation is required nor capa plan is needed.The record will be closed and monitored through tracking and trending (monthly trips and alerts).Summary conclusion: based on the available information and the investigation performed, the complaint will be closed as complaint unconfirmed as analyzed.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: INSET GUARD
• 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: 23449491
• Report Number: 8021545-2025-03001
• Device Sequence Number: 8916712
• Product Code: FPA
• UDI-Device Identifier: 05705244023161
• UDI-Public: 05705244023161
• Combination Product (Y/N): N
• 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): 01/23/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-431AH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown