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) 2021, it was reported that the patient's infusion set's tubing came apart from the quick release.Therefore, the patient's highest blood glucose level was 20 mmol/l.The site location was patient's abdomen or arm, and the pump was clipped on her bra or pants.Moreover, the infusion had been used for few hours or a day for some of them.Reportedly, the infusions were stored in the medicine cabinet.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 80/9 SC1 GREY MCAN
• MDR Report Key: 12405966
• Report Number: 3003442380-2021-00412
• Device Sequence Number: 5002947
• 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

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
• Operator of Device: No Information
• Device Expiration Date: 03/01/2023
• Device Model Number: MMT-975A600
• Device Lot Number: 5313465
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/01/2021
• Patient Sequence Number: 1