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

Model Number	1001682
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Refence number (b)(4) event occured in the united states.It was reported that the patient experienced a high blood glucose level of 500 mg/dl on (b)(6) 2026 with two infusion sets.The infusion set had been in use for 2 days.The patient was treated with a correction bolus administered via the pump.The patient replaced the infusion set and successfully resumed insulin delivery.No further information is available.
Additional Manufacturer Narrative
Initial and final mdr (b)(4) device 1 of 2.

• Brand Name: INSET
• Common Device Name: UNO INSET I 60/6 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, mexico 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, denmark 4320
• MDR Report Key: 24738618
• Report Number: 3003442380-2026-05765
• Device Sequence Number: 17218439
• Product Code: FPA
• UDI-Device Identifier: 05705244016682
• UDI-Public: 05705244016682
• 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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 1001682
• Device Lot Number: 6014740
• 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
• Date Device Manufactured: 08/01/2025
• 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: 58 YR
• Patient Sex: Female