MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. INSET; INSET I 2-PACK 60/6 GREY TCAP

Model Number	1010900
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial and final (b)(4) - device 4 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.
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that the patient faced four insulin flow blocked event on (b)(6) 2026.The blockage was at the site.The infusion set was used for one day.The blood glucose level was high (specific value unknown) and the patient was treated with correction injection via multiple daily injection (mdi) and bolus via pump.The patient replaced infusion sets and resumed insulin deliveries successfully.No further information available.

• Brand Name: INSET
• Common Device Name: INSET I 2-PACK 60/6 GREY TCAP
• 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: 24742687
• Report Number: 3003442380-2026-06106
• Device Sequence Number: 20049382
• Product Code: FPA
• UDI-Device Identifier: 05705244026001
• UDI-Public: 05705244026001
• 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): 03/03/2026

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
• Operator of Device: Lay User/Patient
• Device Model Number: 1010900
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 75 KG