MAUDE Adverse Event Report: MEDTRONIC EXTENDED; UNO EWIS BLUE 60/9 HCAP 3-PK INT

Lot Number 6003789

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 canada on (b)(6) 2024, it was reported that the infusion set's tubing got detached at the tubing connector while the patient was sleeping.The blood glucose level of the patient was 15.6 mmol/l.The site location was patient's abdomen, and the pump was located on the same side.The infusion had been used for three to four hours.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information was available.

• Brand Name: MEDTRONIC EXTENDED
• Type of Device: UNO EWIS BLUE 60/9 HCAP 3-PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18893058
• MDR Text Key: 337518150
• Report Number: 8021545-2024-00128
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244023284
• UDI-Public: 05705244023284
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 6003789
• Initial Date Manufacturer Received: 03/03/2024
• Initial Date FDA Received: 03/13/2024
• Patient Sequence Number: 1