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

Lot Number UNKNOWN

Device Problem Infusion or Flow Problem (2964)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2024, the patient reported that she faced an occlusion alarm and changed the infusion set on wednesday, then again on thursday, but same day (on thursday) her blood glucose level kept going up.Therefore, she went to the hospital on (b)(6) 2024 (friday) at 9:20 am due to high blood glucose level of 600 mg/dl.Currently, her blood glucose level was 214 mg/dl.During hospitalization, the patient received intravenous drip as corrective treatment.At the time of this report, the patient still in the hospital.No further information was 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: 18756292
• MDR Text Key: 335932252
• Report Number: 8021545-2024-00114
• Device Sequence Number: 1
• Product Code: FPA
• 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: 02/22/2024

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 Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 02/22/2024
• Patient Sequence Number: 1