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

Model Number	MMT-941600
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).The patient's mother reported that her son (approximately (b)(6) years of age) felt very agitated because of high blood glucose level.Moreover, he was getting insulin flow block since over a month, random times and noticed leaks under the site.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 46/6 PCC BLUE MCAN
• MDR Report Key: 11441142
• Report Number: 3003442380-2021-00168
• Device Sequence Number: 17156056
• Product Code: FPA
• UDI-Device Identifier: 05705244007338
• UDI-Public: 05705244007338
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 03/01/2022
• Device Model Number: MMT-941600
• Device Lot Number: 5277346
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/08/2021
• Patient Sequence Number: 1