MAUDE Adverse Event Report: MEDTRONIC EXTENDED; UNO EWIS BLUE 60/6 HCAP 10PK INT

Lot Number UNKNOWN

Device Problem Infusion or Flow Problem (2964)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4) event occurred in france on (b)(6) 2024,the patient's parent's reported that their child faced several insulin flow blocked alarms at bolus time.The blood glucose level of the patient was 404 mg/dl and acetone level was 1.3 mmol/l.Therefore, they tried to treat it by changing the catheter and injection with insulin pen.At around 07:00 pm, the acetone level fell to 0.9 mmol/l.No further information was available.

• Brand Name: MEDTRONIC EXTENDED
• Type of Device: UNO EWIS BLUE 60/6 HCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18893038
• MDR Text Key: 337518112
• Report Number: 8021545-2024-00127
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244022683
• UDI-Public: 05705244022683
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/01/2024
• Patient Sequence Number: 1