MAUDE Adverse Event Report: TRUSTEEL; UNO CONTACT DETACH G29 60/6TCAP 10PK INT

Model Number 1002833

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.It was reported that on (b)(6) 2022 and (b)(6) 2022 (unsure of exact dates), the patient's infusion set's tubing disconnected and broke at the pigtail (connector).This issue occurred with four infusion sets.Therefore, her blood glucose level was 600 mg/dl at the time of the event which they tried to treat with correction injection via multiple daily injection.She had moderate ketone levels.Moreover, the infusion set had been used for one day.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 60/6TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 13897352
• MDR Text Key: 287902787
• Report Number: 3003442380-2022-00449
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018426
• UDI-Public: 05705244018426
• Combination Product (y/n): Y
• 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: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/01/2024
• Device Model Number: 1002833
• Device Lot Number: 5345336
• Date Manufacturer Received: 03/10/2022
• Patient Sequence Number: 1