MAUDE Adverse Event Report: MEDTRONIC EXTENDED; UNO EWIS BLUE 60/9 HCAP 10PK INT

Lot Number 6002068

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4) event occurred in the united states on (b)(6) 2023, it was reported that patient's infusion set's tubing was getting pulled and disconnected at the quick release/site connector while the patient was sleeping.The site location was upper side of patient's buttock, with the pump was placed next to the patient.Moreover, the infusion had been used for four days.Reportedly, the infusions were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.There was stress or pull on the tubing and the pump was dropped with the set connected to patient's body.Currently, the patient's blood glucose level was 338 mg/dl.According to the complaint investigation performed on the used device (1 set), it was found that, the tubing was detached from the tubing connector.No further information available.

• Brand Name: MEDTRONIC EXTENDED
• Type of Device: UNO EWIS BLUE 60/9 HCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18755164
• MDR Text Key: 336311630
• Report Number: 8021545-2024-00112
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 6002068
• Date Manufacturer Received: 02/08/2024
• Patient Sequence Number: 1