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

Model Number	MMT-921600
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.(b)(6) 2022, it was reported that on an unknown date (in the year 2019), the patient's infusion set's tubing got detached at the site while working as the nature of her job is physical and it pulled off at work.The site location was patient's abdomen, and the pump was worn on the bra.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.The pump was dropped with the set connected to patient's body.No further information was available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 46/6 PCC PINK MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 15913209
• Report Number: 3003442380-2022-01146
• Device Sequence Number: 6722951
• Product Code: FPA
• UDI-Device Identifier: 05705244007390
• UDI-Public: 05705244007390
• 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): 12/05/2022

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 Model Number: MMT-921600
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2022
• Initial Report FDA Received Date: 12/05/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown