MAUDE Adverse Event Report: MIO; UNO INSET II 80/6 SC1 BLUE MIMX

Model Number	MMT-945A600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in australia on (b)(6) 2023, it was reported that the patient inserted the infusion set on (b)(6) 2023 and it came apart on (b)(6) 2023 at the site connector while he was sleeping.The site location was patient's tummy.The infusion had been used for three days.Reportedly, the patient was unsure whether there was stress or pull on the tubing.Further, the pump was not dropped with the set connected to patient's body.In the morning ((b)(6) 2023), his blood glucose level was 11 mmol/l.No further information was available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 80/6 SC1 BLUE MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 17036853
• Report Number: 3003442380-2023-00271
• Device Sequence Number: 20557337
• Product Code: FPA
• UDI-Device Identifier: 05705244020368
• UDI-Public: 05705244020368
• Combination Product (Y/N): Y
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2023

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
• Device Model Number: MMT-945A600
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/01/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown