MAUDE Adverse Event Report: MIO; UNO INSET II 46/6 SC1 PINK MCAN

Model Number	MMT-921A600
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 canada.On (b)(6) 2022, the patient reported that the infusion set's tubing came apart at the tubing connector while he was inserting the infusion set.The site location was patient's abdomen, and the pump was located on the other side of the abdomen.Moreover, the infusion had been used for one day.Reportedly, the infusions were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with set connected to patient's body.No further information was available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 46/6 SC1 PINK MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 15400892
• Report Number: 3003442380-2022-01009
• Device Sequence Number: 6124008
• Product Code: FPA
• UDI-Device Identifier: 05705244020214
• UDI-Public: 05705244020214
• 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): 09/12/2022

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 Expiration Date: 10/01/2023
• Device Model Number: MMT-921A600
• Device Lot Number: 5338957
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2022
• Initial Report FDA Received Date: 09/12/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown