MAUDE Adverse Event Report: UNOMEDICAL UM-D CONVATEC INSET; UNO INSET I 80/6 GREY BETA 10PK BETA

Model Number	FG000016-05
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that patient forgot to remove the needle guard from the cannula event on (b)(6) 2024.The blood glucose level was 348 mg/dl.No further information available.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
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: the information in this complaint (b)(4) has been evaluated.The batch 6007070 in question was manufactured at the reynosa site.Investigation process of the complaint was carried out in accordance with work instruction (wi) guidance for visual testing for complaints area version 03 for the code insertion without removing needle guard.Complaint investigations.Photo/sample was not provided.In order to test the product, the reference samples from the lot have been requested.Test results: visual test according to wi version 3 on reference samples, 10 samples out 10 samples passed the test.Device history record (dhr) review: packaging: the lot 6007070 was manufactured according to the wi version 114 and manufactured in the line 7, on 13/may/2024, with a total of (b)(4) units.Trending: a query was run in database on 15/apr/2025 against malfunction code insertion without removing needle guard and lot 6007070 and no other complaint have been registered in database for the same lot 6007070 and malfunction code.Conclusion summary of complaint investigation: as a result of the following: no defect on tests for reference samples, no non-conformance (nc) raised during production related to complaint code, no other complaint received on the lot in question and malfunction code, no further actions are required.This complaint will not require further root cause investigation nor capa plan.Therefore, this issue will be monitored through the post market surveillance activities.

• Brand Name: CONVATEC INSET
• Common Device Name: UNO INSET I 80/6 GREY BETA 10PK BETA
• Manufacturer (Section D): UNOMEDICAL UM-D; ave. fomento industrial l9 m3; parque industrial del norte; reynosa , tamps., mexico 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 21132488
• Report Number: 3003442380-2024-36284
• Device Sequence Number: 15199205
• Product Code: FPA
• UDI-Device Identifier: 05705244026254
• UDI-Public: 05705244026254
• Combination Product (Y/N): Y
• 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): 05/10/2025

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: FG000016-05
• Device Lot Number: 6007070
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 05/10/2025
• Initial Report FDA Received Date: 01/11/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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 Sex: Unknown