MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. INSET; UNO INSET I 60/6 GREY TCAP 10PK INT

Model Number	1001680
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that the patient experienced cannula issues with four infusion sets over the past year.The patient stated that the infusion set cannulas were kinked, and symptoms were noticed more than three hours after insertion.Each infusion set had been in use for less than one day and was inserted in the abdomen.One event resulted in high blood glucose, reported as high, and was treated with a correction injection.The patient replaced the infusion set and successfully resumed insulin delivery.No further information available.
Additional Manufacturer Narrative
Initial and final mdr (b)(4) - device 2 of 4.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.Investigation in progress.

• Brand Name: INSET
• Common Device Name: UNO INSET I 60/6 GREY 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: 24738132
• Report Number: 3003442380-2026-05375
• Device Sequence Number: 8879586
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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
• Operator of Device: Lay User/Patient
• 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: 03/02/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR
• Patient Sex: Female