MAUDE Adverse Event Report: MEDTRONIC EXTENDED; UNO EWIS BLUE 60/6 HCAP 3-PK INT

Lot Number UNKNOWN

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 the infusion set was inserted at patient's abdomen on (b)(6) 2024, at 06:00 pm.In the morning of (b)(6) 2024, they received an alert and at night, the patient's blood glucose level reached to 33 mmol/l.Therefore, the patient's mother noticed that her child's infusion set was dislodged from the site.No further information was available.

• Brand Name: MEDTRONIC EXTENDED
• Type of Device: UNO EWIS BLUE 60/6 HCAP 3-PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18805773
• MDR Text Key: 337518374
• Report Number: 8021545-2024-00119
• 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: 02/29/2024

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?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/22/2024
• Patient Sequence Number: 1