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

Model Number	MMT-941A600
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial and final (b)(4) - mdr 3003442380-2024-09431 - device 1 of 3.E1 patient city: (b)(6).Patient country: canada.
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the canada.It was reported issues with 3 infusion sets where 2 infusion sets fell off after 2 hours and the third one fell off after 24 hour.No further information available.

• Brand Name: UNO INSET II 46/6 SC1 BLUE MCAN
• Common Device Name: MINIMED MIO
• 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: 19590405
• Report Number: 3003442380-2024-09431
• Device Sequence Number: 14329053
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2024

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?: No
• 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: 05/21/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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