MAUDE Adverse Event Report: UNOMEDICAL A/S MINIMED MIO; UNO INSET II 46/6 SC1 BLUE MCAN

Model Number	MMT-941A600
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: canada.
Event or Problem Description
Reference number (b)(4).Event occurred in canada, it was reported that on (b)(6) 2024 occlusion alarm occurred and insulin slowly exit through tubing after troubleshooting.No further information available.
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 complaint (b)(4) has been evaluated.The batch 6000281 in question was manufactured at the reynosa site.Investigation process of the complaint was carried out in accordance with work instructions guidelines for test of reference samples buid-umd version 11 for the code occlusion in the tubing and/or tubing connectors (e.G., occlusion alarm from the infusion pump may have sounded).Complaint investigations.Photo/sample was not provided.In order to test the product, the reference samples from the lot has been requested.The following test was performed: visual test according to with work instructions version 18 and version 39 test on returned unused/used/reference samples, 10 samples out 10 samples passed the test.Functional test 1 according to with work instructions version 11 test on returned unused/used/reference samples, 10 samples out 10 samples passed the test.A batch record review was conducted resulting in the following: the lot 6000281 was manufactured according to the document version 31 on the packing process in the machine l171, on 13/mar/2023, with a total of (b)(4) units.Review of the device history records (dhr) showed that all relevant tests required during the related process had been fulfilled and met the requirements.Conclusion summary of the related event: as a result of the following: no reported harm, no defect on test, no non-confromance (nc) raised during production.No further actions are required.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: MINIMED MIO
• Common Device Name: UNO INSET II 46/6 SC1 BLUE MCAN
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 20381395
• Report Number: 3003442380-2024-27750
• Device Sequence Number: 12403792
• Product Code: FPA
• UDI-Device Identifier: 05705244020306
• UDI-Public: 05705244020306
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160648
• 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): 10/21/2024

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 Expiration Date: 02/01/2026
• Device Model Number: MMT-941A600
• Device Lot Number: 6000281
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2023
• 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