MAUDE Adverse Event Report: UNOMEDICAL A/S MIO; UNO INSET II 80/6 SC1 BLUE MIMX

Model Number	MMT-945A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: australia.
Event or Problem Description
Reference number (b)(4).Event occurred in australia.This mdr is being submitted for an unknown number of devices in which the issue was experienced.On (b)(6) 2024, it was reported that patient faced infusion set cannula bent.Patient was admitted to hospital due to any blood glucose value, diabetic ketoacidosis seizure and diabetic coma.Length of hospitalization was for two nights.Date of hospitalization was (b)(6) 2024.The blood glucose level was at time of hospitalization was 22.2 mmol/l.Nausea, dehydration headaches symptoms were reported at time of hospitalization.Therefore, patient was treated with intravenous.Company do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.
Additional Manufacturer Narrative
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, the information in this complaint (b)(6) has been evaluated.The batch 6005828 in question was manufactured at the reynosa site.Investigation process of the complaint was carried out in accordance with work instruction (wi) guidance for visual testing for complaints area version 3 and wi guidance for functional testing for complaints area version 2 for the code soft cannula found bent upon removal from infusion site.Complaint investigations.Photo/sample was not provided.In order to test the product, the reference samples from the lot have been requested.Test results: visual test according to wi version 3 on reference samples, reference samples passed the test.Functional (flow) test according to wi version 2 on reference samples, reference samples passed the test.Device history record (dhr) review: the lot 6005828 was manufactured according to the wi version 69, manufactured in the line inset 4, on 02/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 were identified; no maintenance events were recorded.Trending: a query was run in database on 18/aug/2025 against malfunction code soft cannula found bent upon removal from infusion site and lot 6005828 and other 2 complaint have been registered in database for the same lot and malfunction code.Preliminary conclusion: due to the volume of complaints identified in the trending analysis, this case will be moved to pending corrective and preventive action (capa) determination assessment to evaluate whether additional investigation is required.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: MIO
• Common Device Name: UNO INSET II 80/6 SC1 BLUE MIMX
• 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: 20396552
• Report Number: 3003442380-2024-28604
• Device Sequence Number: 6546047
• Product Code: FPA
• UDI-Device Identifier: 05705244020368
• UDI-Public: 05705244020368
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160648
• 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): 08/18/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-945A
• Device Lot Number: 6005828
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2024
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown