MAUDE Adverse Event Report: UNOMEDICAL UM-D INSET; UNO INSET I 60/6 GREY TCAP 10PK INT

Model Number	1001680
Medical Device Problem Codes	Infusion or Flow Problem (2964); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial and final (b)(4) - device 1 of 2.Request was performed for additional information including lot number; however, lot number was not provided.A complaint investigation was initiated under complaint investigation.Unfortunately, no specific lot number was identified, which limits the ability to trace or analyze a particular item.
Event or Problem Description
This emdr is being submitted for unknown number of quantity.Reference number (b)(4).Event occurred in the united states the patient reported experiencing a bent cannula event on (b)(6) 2025, which disrupted insulin delivery and resulted in hyperglycemia.The elevated blood glucose was successfully managed by the patient through self-administration, resolving the issue with no further complications.No further information available.

• Brand Name: INSET
• Common Device Name: UNO INSET I 60/6 GREY TCAP 10PK INT
• Manufacturer (Section D): UNOMEDICAL UM-D; 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: 24741303
• Report Number: 3003442380-2026-05958
• Device Sequence Number: 12176949
• Product Code: FPA
• UDI-Device Identifier: 05705244016620
• UDI-Public: 05705244016620
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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?: Yes
• Device Model Number: 1001680
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male