MAUDE Adverse Event Report: MIO; UNO INSET II 60/6 SC1 PINK MCAN

Model Number	MMT-923A600
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 (b)(6).On (b)(6) 2021, it was reported that the patient's infusion set's tubing came apart at the site location while the patient was sleeping/going to the bathroom a day after the insertion.The site location was left and right side of patient's abdomen.The pump was sometimes located on the same side or on the opposite side in relation to the site.Reportedly, the infusions were stored at home.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 60/6 SC1 PINK MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 13123334
• Report Number: 3003442380-2021-00885
• Device Sequence Number: 13910847
• Product Code: FPA
• UDI-Device Identifier: 05705244020245
• UDI-Public: 05705244020245
• 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): 12/31/2021

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: 03/01/2024
• Device Model Number: MMT-923A600
• Device Lot Number: 5348387
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 12/31/2021
• Patient Sequence Number: 1
• Patient Sex: Unknown