MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. INSET II; UNO INSET II 60/9 PINK TCAP 10PK INT

Model Number	1002822
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4) event occurred in the united states.It was reported that the patient experienced an event in which he forgot to remove needle guard and noticed after insertion on (b)(6) 2025.The blood glucose levels was high and patient then replaced infusion set and resumed insulin deliveries successfully.No further information available.
Additional Manufacturer Narrative
Correction: this mdr is being submitted to correct the submitted common device name under d2, model number, serial number, primary unique device identifier (udi) 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.Complaint investigation results: a complaint investigation has been initiated to review the device history record (dhr) associated with the reported issue.The batch 6009171, in question was manufactured at the reynosa site.Device history record (dhr) review: the lot 6009171 was packaging according to work instruction (wi) version 116 in the line 07, on 09/sep/2024, 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: 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.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: INSET II
• Common Device Name: UNO INSET II 60/9 PINK TCAP 10PK INT
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; ave. fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p., 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1 - 3; osted; lejre, 4320
• MDR Report Key: 23449432
• Report Number: 3003442380-2025-15727
• Device Sequence Number: 8961067
• Product Code: FPA
• UDI-Device Identifier: 05705244018273
• UDI-Public: 05705244018273
• 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): 11/28/2025

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: 1002822
• Device Lot Number: 6009171
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Weight: 87 KG