MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. INSET II; UNO INSET II 80/9 SC1 GREY MIMX

Model Number	MMT-975A
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in the united arab emirates.It was reported that the patient faced insulin flow blocked alarm event on (b)(6) 2025.The blockage was in the tubing.No further information available.
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: united arab emirates.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
The initial mdr with manufacturing report number (3003442380-2025-13629), was submitted on 12-sep-2024.Upon completion of the investigation, the manufacturing date was updated as 13-jan-2024.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: complaint investigation results: a complaint investigation has been initiated under complaint investigation child record (b)(4).The batch 6004909, in question was manufactured at the reynosa site.Device history record (dhr) review: the lot 6004909 was manufactured according to the work instruction (wi) version 66 and manufactured in the line l-4 on 13-jan-2024, with a total of (b)(4) units.The sub-assembly: gluing of tubing of the lot 4a03672 was manufactured according to the wi version 59 and manufactured in the machine sc09, on 15-jan-2024, with a total of (b)(4) units.The sub-assembly: gluing of tubing of the lot 4a01542 was manufactured according to the wi version 59 and manufactured in the machine sc04, on 12-jan-2024, 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 was identified, nor maintenance events were recorded related to complaint code.Conclusion summary of complaint investigation: as a result of the following: no non-conformance (nc) raised during production related to complaint code, no trend identified for 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.

• Brand Name: INSET II
• Common Device Name: UNO INSET II 80/9 SC1 GREY MIMX
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; ave, fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p., mexico 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 23034932
• Report Number: 3003442380-2025-13629
• Device Sequence Number: 9217042
• Product Code: FPA
• UDI-Device Identifier: 05705244020184
• UDI-Public: 05705244020184
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032854
• 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): 09/27/2025

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 Model Number: MMT-975A
• Device Lot Number: 6004909
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 09/27/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2024
• 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
• Patient Sex: Unknown