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	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial and final mdr (b)(4) device 3 of 3.
Event or Problem Description
Reference number (b)(4) event occurred in canada.It was reported that patient faced infusion set leaking issue on (b)(6) 2025 and the infusion set tubing was split in half due to which the patient faced hyperglycemia event.The issue occured with 3 infusion sets and was occured in sometime in (b)(6) 2025, event 2: end of august 2025, event 3: (b)(6) 2026.The blood glucose level was high and the patient was treated with correction bolus via pump.The patient replaced the infusion set and resumed insulin deliveries successfully.No further information available.
Additional Manufacturer Narrative
Supplemental report 01 (b)(4) mdr 3003442380-2026-00505.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 under d4.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: electronic quality management system (eqms) search: a query was run in the eqms on 05-mar-2026 against "lot number" "6014835" and similar malfunction codes: tubing damage - significant / extensive, tubing is split (along the length of the tubing) or has pinholes.The review confirmed that lot 6014835 and the identified failure mode are not associated with any nonconforming reports (ncr)s or corrective and preventive action (capa)s of the same or similar nature.Similar complaints search: a query was run in the eqms on 05-mar-2026 against "lot number" criteria equal "6014835" and similar malfunction codes: tubing damage - significant / extensive, tubing is split (along the length of the tubing) or has pinholes.The count of complaints is 1.The complaints numbers are (b)(4).Device history record (dhr) review: the lot 6014835 was manufactured according to the work instruction (wi) version 125 and manufactured in the line inset 1, on 14-aug-2025 with a total of (b)(4) units.Glue-tubing lot: the lot 5h00090 was manufactured according to wi version 69 and manufactured in the machine sc01, on 07-aug-2025 with a total of (b)(4) units.The lot 5h00101 was manufactured according to wi version 69 and manufactured in the machine sc01, on 08-aug-2025 with a total of (b)(4) units.The device history record (dhr) was reviewed in accordance with applicable procedures.All required in-process and final tests were completed and met specified requirements.No deviations were identified, and no maintenance events were recorded that relate to the complaint code.Conclusion: dhr review supports compliance with manufacturing and quality requirements; no issues noted.Visual evidence review: no photo was provided to support visual confirmation of the reported issue.Conclusion: unable to perform visual verification; assessment based on available documentation only.Capa determination assessment - conclusion summary of complaint investigation: based on the investigation, no further investigation is required.The record will be closed and monitored through tracking and trending per wi (monthly trips and alerts).Complaint unconfirmed: following investigation the reported failure could not be confirmed for this complaint.Conclusion summary of complaint investigation: as a result of the following a comprehensive review was conducted, including eqms queries, similar complaint searches, device history record review, visual evidence assessment, and capa determination.No ncrs or capas of the same or similar nature were found for lot 6014835 and related malfunction codes for leakage.One complaint was identified for this lot, but no trend or systemic issue was detected.The manufacturing records confirmed that the lot was produced in compliance with all requirements, with no deviations or maintenance events noted.No photo evidence was provided, so the assessment was based on documentation only.Based on these results, no manufacturing or quality issues were identified, and no further investigation is required.The record will be closed and monitored through routine tracking and trending.
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: 24311709
• Report Number: 3003442380-2026-00505
• Device Sequence Number: 12155862
• 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): 03/05/2026

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: 6014835
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• 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
• Patient Age: 45 YR
• Patient Sex: Female