MAUDE Adverse Event Report: MIO; UNO INSET II 46/6 SC1 BLUE MIMX

Model Number	MMT-941A
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in australia on (b)(6) 2024, it was reported by the patient that he was hospitalized for 7 hours due to hyperglycemia episode and high ketones.He received an infusion flow block alarm from two sets.Patient also reporting that her pump is not delivering auto correction.High blood glucose level was 27 mmol/l.It was corrected by the hospitalization treatment and via bolus pump.No further information was available.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Correction: this mdr is being submitted to correct the submitted model number, serial number, expiration date under d4 and manufacturing date under h4.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 6003511 in question was manufactured at the reynosa site.The reference samples for the lot 6003511 have already been previously tested for visual inspection and tested for flow in the complaint (b)(4) on 12/feb/2024.All test results were found within specifications as per the test report (b)(4) test report.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 work instruction (wi) version 3.0 on reference samples, 10/10 samples passed the test.Functional air flow test according to wi version 2.0 on reference samples, 10/10 samples passed the test.Device history record (dhr) review: the lot 6003511 was manufactured according to the wi version 65 manufactured in the line inset 6, on 09/oct/2023, 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 related to the malfunction reported, no maintenance events were recorded.Trending: a query was run in on 05/aug/2025 against malfunction code occlusion (e.G., occlusion alarm from the infusion pump may have sounded).(source/cause cannot be identified, only use when a specific malfunction cannot be determined).If there is no troubleshooting, inconclusive troubleshooting, or partial troubleshoot done and it cannot be concluded to be infusion related, refer to cannot be determined cannot be determined.No escalation required and lot 6003511 and no other complaints have been registered in database for the same lot 6003511 and malfunction code.Conclusion summary of the related event: as a result of the following: on the investigation on reference samples, no issue were found related to occlusion, harm no reportable, no defect on tests, no non-conformance (nc) raised during production, no more complaint was received on the lot in question and malfunction, no further action are required, therefore, this issue will be monitored through the post market surveillance activities.

• Brand Name: MIO
• Common Device Name: UNO INSET II 46/6 SC1 BLUE MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19369275
• Report Number: 3003442380-2024-02721
• Device Sequence Number: 7725080
• Product Code: FPA
• UDI-Device Identifier: 05705244020009
• UDI-Public: 05705244020009
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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?: No
• Device Expiration Date: 09/07/2026
• Device Model Number: MMT-941A
• Device Lot Number: 6003511
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown