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

Model Number	MMT-923A
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: new zealand.
Event or Problem Description
Unomedical reference number (b)(4) event occurred in new zealand it was reported that patient faced infusion set occlusion event on 06-feb-2024.Insulin does not exist with plunger.No further information available.
Additional Manufacturer Narrative
Correction: this mdr is being submitted to correct the submitted expiration date under d4.The initial mdr with manufacturing report number (3003442380-2024-11301), was submitted on 01-jul-2024.Upon completion of the investigation, the manufacturing date was updated as 30-oct-2023.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.Per revision 21 of procedure (b)(4), a child investigation is not required to document the dhr review for a type 2 reportable complaint.However, the child was created to allow the parent record to advance to review and summary.Since it was created, the dhr review was documented within the child.Complaint investigation results: a complaint investigation has been initiated under complaint investigation child record (b)(4).The batch 6002628, in question was manufactured at the reynosa site.Device history record (dhr) review: the lot 6002628 was manufactured according to the work instruction (wi) version 108 and manufactured in the line inset 7 on 30-oct-2023, with a total of (b)(4) units.Gluing tube: the sub-assembly, gluing tube of the lot 3g05474 was manufactured according to the w version 55 and manufactured in the machine sc02, on 12-aug-2023, with a total of (b)(4) units.The sub-assembly, gluing tube of the lot 3g05475 was manufactured according to the wi version 55 and manufactured in the machine sc02, on 13-aug-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 was identified, nor maintenance events were recorded related to complaint code.Conclusion summary of complaint investigation: no non-conformance (nc) raised during production related to complaint 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.

• Brand Name: MINIMEDÂ MIOÂ
• 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: 19644275
• Report Number: 3003442380-2024-11301
• Device Sequence Number: 7480039
• Product Code: FPA
• UDI-Device Identifier: 05705244019942
• UDI-Public: 05705244019942
• 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): 11/15/2025

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: 07/12/2026
• Device Model Number: MMT-923A
• Device Lot Number: 6002628
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 11/15/2025
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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