MAUDE Adverse Event Report: UNOMEDICAL A/S MIO; UNO INSET II 60/6 SC1 PINK MIMX

Model Number	MMT-923A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	08/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: united states.
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that patient was hospitalized on (b)(6) 2024 due to diabetic ketoacidosis and bent cannula event.Blood glucose at the time of event was 450 mg/dl.The duration of hospitalization was greater than 24 hours.Patient was also found positive for moderate ketones.Patient was treated with insulin via intravenous (iv) drip.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 was 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)(4) has been evaluated.The batch 5404804 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 5404804 was manufactured according to the wi version 58, manufactured in the line inset 6, on 12/dec/2022, 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 5404804 and no other complaint have been registered in database for the same lot and malfunction code.Conclusion summary of complaint investigation: as a result of the following: no defect on tests for reference samples related to the complaint, no non-conformance (nc) raised during production related to complaint code, no other complaint received on the lot in question and malfunction code, 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.
Event or Problem Description
To date no additional patient or event details have been received.
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)(4) has been evaluated.The batch 5404804 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 5404804 was manufactured according to the wi version 58, manufactured in the line inset 6, on 12/dec/2022, with a total of (b)(4) units.Review of the device history record (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 5404804 and no other complaint have been registered in database for the same lot and malfunction code.Conclusion summary of complaint investigation: as a result of the following: no defect on tests for reference samples related to the complaint, no non-conformance (nc) raised during production related to complaint code, no other complaint received on the lot in question and malfunction code, 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.Corrective and preventive action (capa) determination results: this complaint falls under the scope of the corrective and preventive action (capa) 1768101: "autosoft 90, kinked soft cannula issues" and will cover inset i (autosoft xc dhf-13.8 & 13.13) and inset ii (autosoft 90 dhf-14 and 14.3) products.Root cause of problem: the root cause has been identified as: method, manpower, measurement, machine: corrective action as a result of the investigation: the action plan and deadlines is as followed: the following actions were already implemented in the non-conformance (nc) 1515780 1.Include the defect in document (b)(4) (work instruction inset line) 2.Improve guards of the conveyors 3.Update trays for the stock of cannulas 4.Update document (b)(4) (quality specification for catheter fixture for skewed catheters) for include the handling of the catheter during the process.5.Update the document (b)(4) (work instruction inset line) to include the preventive actions implemented in the process (trays).A remaining action (to address design root cause) and deadlines is as followed: add cylinders to the lid to maintain in position the needle and cannula during transportation and prior use (database (b)(4) - (b)(6) 2025).

• Brand Name: MIO
• Common Device Name: UNO INSET II 60/6 SC1 PINK 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: 20784292
• Report Number: 3003442380-2024-32817
• Device Sequence Number: 8948955
• Product Code: FPA
• UDI-Device Identifier: 05705244019942
• UDI-Public: 05705244019942
• Combination Product (Y/N): Y
• 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,Followup
• Report Date (Section B): 09/12/2025

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 Expiration Date: 11/10/2025
• Device Model Number: MMT-923A
• Device Lot Number: 5404804
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 09/03/2025; 09/12/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 09/05/2025; 10/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• 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