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

Model Number	MMT-923A600
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hypoglycemia (1912)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6) 2021, the patient's mother reported that the patient received insulin flow block.The blood glucose level was reported as 7.4 mmol/l and the infusion set had been used for few hours.Reportedly, the site of insertion was the patient's arm.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 60/6 SC1 PINK MCAN
• MDR Report Key: 12679515
• Report Number: 3003442380-2021-00622
• Device Sequence Number: 1206391
• Product Code: FPA
• UDI-Device Identifier: 05705244020245
• UDI-Public: 05705244020245
• 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): 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 04/01/2024
• Device Model Number: MMT-923A600
• Device Lot Number: 5350758
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 10/22/2021
• Patient Sequence Number: 1