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

Model Number	MMT-965A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Patient country: australia.
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in australia.It was reported that the patient faced issue of infusion set needle break on (b)(6) 2024.Patient had difficulty in inserting the infusion set.The set was in use for les than 1 day.The insertion site was abdomen.The fracture occured during the timeof insertion and the needle was also hard to remove.The blood glucose level was 15mmol/l.No further information available.
Additional Manufacturer Narrative
Correction: this mdr is being submitted to correct the submitted expiration date under d4.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 3709030, a child investigation is not required to document the device history record (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 5408470, in question was manufactured at the reynosa site.Dhr review: the lot 5408470 was manufactured according to the work instruction (wi) version 50 and manufactured in the line inset 6 on 03-jan-2023, with a total of (b)(4) units.Review of the dhr showed that an extended inspection was created due to dislodged tube, extended inspection was found within specification.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.Extended inspection is not related with the claimed malfunction 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: MIO
• Common Device Name: UNO INSET II 80/6 SC1 GREY 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: 19622116
• Report Number: 3003442380-2024-10427
• Device Sequence Number: 8178539
• Product Code: FPA
• UDI-Device Identifier: 05705244020153
• UDI-Public: 05705244020153
• 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): 11/11/2025

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: 12/02/2025
• Device Model Number: MMT-965A
• Device Lot Number: 5408470
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• 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