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

Lot Number	6002628
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) 2024, it was reported that patient's infusion set's tubing was detached near quick release while the patient was changing clothes.The site location was left side of patient's buttock, with the pump located on the left side.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 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 MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18833947
• Report Number: 3003442380-2024-00168
• Device Sequence Number: 20639748
• Product Code: FPA
• UDI-Device Identifier: 05705244019942
• UDI-Public: 05705244019942
• Combination Product (Y/N): N
• 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): 03/04/2024

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: 07/01/2026
• Device Lot Number: 6002628
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/04/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown