MAUDE Adverse Event Report: MIO; UNO INSET II 80/9 SC1 GREY MCAN

Model Number	MMT-975A600
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, it was reported that the infusion set's tubing was no longer connected on the other end close to the site location.Therefore, her blood glucose level was 18.8 mmol/l at the time of this event.Moreover, the infusion had been used two days prior of this event.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, her blood glucose level was 9.6 mmol/l.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 80/9 SC1 GREY MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 13691432
• Report Number: 3003442380-2022-00376
• Device Sequence Number: 1906032
• Product Code: FPA
• UDI-Device Identifier: 05705244020429
• UDI-Public: 05705244020429
• 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): 03/08/2022

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: 06/01/2024
• Device Model Number: MMT-975A600
• Device Lot Number: 5355970
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/08/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown