MAUDE Adverse Event Report: TRUSTEEL; UNO CONTACT DETACH G29 80/8TCAP 10PK INT

Lot Number 6002652

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 it was reported that a 17-year-old male child patient's infusion set was not working, and this issue occurred with 3 infusion sets.Therefore, his blood glucose level was 33.3 mmol/l at the time of this event which they tried to treat with correction bolus via pump.Further, they replaced the infusion set and insulin was resumed successfully.No further information available.

• Brand Name: TRUSTEEL
• Type of Device: UNO CONTACT DETACH G29 80/8TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19104263
• MDR Text Key: 340135022
• Report Number: 3003442380-2024-00224
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018518
• UDI-Public: 05705244018518
• Combination Product (y/n): N
• PMA/PMN Number: K041545
• 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: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 6002652
• Date Manufacturer Received: 04/05/2024
• Patient Sequence Number: 1