MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. INSET I; UNO INSET I 80/6 GREY BETA 10PK BETA

Model Number	FG000016-05
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	04/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that patient experienced an event of infusion set bent cannula which led to high blood glucose.On (b)(6) 2025, patient was hospitalized due to diabetic ketoacidosis and high blood glucose levels.The blood glucose levels was 285 mg/dl and lasted three hours.The patient felt awful and diagnosed with eugenic dka and later received intravenous drip and glucagon as a corrective treatment in the hospital.The trace ketones were also present.The patient released from the hospital on (b)(6) 2025.Company do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.
Additional Manufacturer Narrative
H11: since no lot number is available, a detailed investigation, tests on reference samples or batch review cannot be conducted.Therefore, this complaint will be closed, this issue will be monitored through pms product trends and malfunction.If any trends picked up, this will flag on the trips and alerts according to the omqr procedure.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Unomedical hereby submits this supplemental report as part of its complaint remediation activities conducted under a capa/fda action plan.This submission includes a retrospective reassessment of previously evaluated complaints.Unomedical is providing this supplemental information in accordance with the reporting requirements set forth in 21 cfr part 803.Any fields left blank indicate that the information is unknown, unavailable, or remains unchanged.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.A complaint investigation was conducted based on the event description and the assigned malfunction code soft cannula bent/kinked/crimped after removal -blockage.Additional information was requested to support the investigation; however, a lot number information was not provided.No device, device components, or other visual or physical evidence was made available for evaluation.Consequently, visual inspection, retain-sample testing, or the assessment of potential product performance issues, component integrity, or manufacturing defects could not be performed.In response to the complaint and due to the absence of a specific lot number, a high level investigation was conducted for the inset product family and the assigned malfunction.The investigation encompassed an electronic quality management system (eqms) search, assessment of complaint trends, and the review of risk management files.No systemic issues were identified.Please refer to the attached memo for full details: inset_lopi-cannula.Pdf.Enclosure 1: eqms search results.Enclosure 2: maintenance results.Enclosure 3: raw data for complaint trending.Corrective and preventive action (capa) plandetermination.Based on the investigation, no further action is required.The record will be closed and monitored through tracking and trending per work instruction (wi) (monthly trips and alerts).Complaint unconfirmed: following investigation, the reported failure could not be confirmed for this complaint.Complaint investigation - conclusion due to the absence of a lot number and returned product, the investigation was limited to a high level review of the inset product family, including an eqms search, complaint trending, and review of applicable risk management documentation.No evidence of a systemic issue was identified.No further action is required at this time, and the record will be closed with continued monitoring through routine tracking and trending.The record may be reassessed if additional information becomes available.

• Brand Name: INSET I
• Common Device Name: UNO INSET I 80/6 GREY BETA 10PK BETA
• 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: 22058621
• Report Number: 3003442380-2025-09286
• Device Sequence Number: 15416235
• Product Code: FPA
• UDI-Device Identifier: 05705244026254
• UDI-Public: 05705244026254
• 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): 01/26/2026

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: FG000016-05
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown