MAUDE Adverse Event Report: MIO; UNO INSET II 60/6 SC1 BLUE MIMX

Lot Number 5352400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2021, it was reported that the patient experienced confusion, feeling sick, unwell, altered vision and her highest blood glucose level was 675 mg/dl.Further, it is stated that her infusion sets were leaking.Consequently, she was admitted to the hospital on (b)(6) 2021 at 4:00 pm with blood glucose level of 670 mg/dl.Moreover, the patient was still in the hospital at the time of this report.No further information available.

• Brand Name: MIO
• Type of Device: UNO INSET II 60/6 SC1 BLUE MIMX
• MDR Report Key: 12363883
• MDR Text Key: 268036625
• Report Number: 3003442380-2021-00389
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244020030
• UDI-Public: 05705244020030
• Combination Product (y/n): Y
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• 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
• Device Operator: No Information
• Device Expiration Date: 04/01/2024
• Device Lot Number: 5352400
• Initial Date Manufacturer Received: 08/02/2021
• Initial Date FDA Received: 08/25/2021
• Type of Device Usage: N
• Patient Sequence Number: 1