MAUDE Adverse Event Report: MIO ADVANCE; UNO MIO ADV. GREY 60/6 SC1 10-PK INT

Model Number MMT-242A

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number: (b)(4).Event occurred in the united states.On (b)(6) 2022, the patient reported that yesterday, she inserted a new infusion set and her site came out in the middle of the night due to which she experienced high blood glucose level.Therefore, she got up and went to change the pump site.Yesterday ((b)(6) 2022), at 15:00 hours, the patient went to the emergency room due to diabetic ketoacidosis with blood glucose level of 630 mg/dl.She herself tested for ketone levels it was dark purple, two or above, the highest one she got when she tested.While in the emergency room, the patient received infusion drip intravenously and then going to take her off and give manual injection as corrective treatment.At the time of this report ((b)(6) 2022), she was still in the hospital and her blood glucose level was 190 mg/dl.No further information available.

• Brand Name: MIO ADVANCE
• Type of Device: UNO MIO ADV. GREY 60/6 SC1 10-PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 13616382
• MDR Text Key: 288021838
• Report Number: 8021545-2022-00113
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018877
• UDI-Public: 05705244018877
• Combination Product (y/n): Y
• PMA/PMN Number: K173879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MMT-242A
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/18/2022
• Patient Sequence Number: 1