MAUDE Adverse Event Report: MEDTRONIC EXTENDED; UNO EWIS BLUE 110/9 HCAP 1-PK INT

Lot Number 5413270

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4) event occurred in canada on (b)(6) 2024, it was reported that a 12-year-old male child patient experienced high blood glucose level (16.5 mmol/l) for few hours.Therefore, they changed the infusion set.No further information available.

• Brand Name: MEDTRONIC EXTENDED
• Type of Device: UNO EWIS BLUE 110/9 HCAP 1-PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18665799
• MDR Text Key: 334838196
• Report Number: 8021545-2024-00106
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K210544
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 5413270
• Date Manufacturer Received: 02/01/2024
• Patient Sequence Number: 1