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

Lot Number 5360976

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 25-feb-2024, it was reported that the patient felt tired/weak, experienced high blood glucose level and the infusion set tape was not sticking to patient's body.Therefore, on (b)(6) 2024, the patient was admitted to the hospital due to diabetic ketoacidosis with blood glucose level of 791 mg/dl.During hospitalization, the patient received insulin drip intravenously as corrective treatment.After staying for 11 days in the hospital, the patient was released.At the time of this report, the patient's blood glucose level was 195 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: 18805170
• MDR Text Key: 336506353
• Report Number: 8021545-2024-00118
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 5360976
• Date Manufacturer Received: 02/26/2024
• Patient Sequence Number: 1