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

Lot Number	UNKNOWN
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) 2022, the patient's mother reported that her daughter had leaking on the infusion set's tubing and connector in all eight infusion sets.She got them last month which she started using two weeks ago.One time her daughter told her that her pants were wet because of the leakage and the pump smells insulin.This issue occurred because the infusion set's tubing came apart at the connector during insertion.Reportedly, the infusion had been used for two days.The site location was patient's belly and thigh.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 the set connected to the patient's body.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 46/6 SC1 PINK MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14285681
• Report Number: 3003442380-2022-00612
• Device Sequence Number: 6209911
• Product Code: FPA
• UDI-Device Identifier: 05705244019911
• UDI-Public: 05705244019911
• 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): 05/04/2022

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 Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/05/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown