MAUDE Adverse Event Report: UNOMEDICAL A/S TRUSTEEL INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Patient Problems Hyperglycemia (1905); Malaise (2359)

Event Date 04/11/2024

Event Type  Injury  

Event Description

I wear the tandem x2 diabetes pump with the truesteel infusion sets.I have had multiple occlusion alarms and the pump stops delivering insulin.This happened to me today at midnight.I put on a new infusion set( my current cgm reading at that time was high).I woke up at 3:00 am to the same issue with 316.I feel sick.This has happened multiple times.It also happened a year ago and i called support.I called support today.Both time i removed the infusion set and ran the insulin through to see where the occlusion was.I took the infusion set apart and could see the drops coming out where it snaps together.When i snapped it back together while running the insulin started to flow through the tip.There were no air bubbles in the tubing either.Reference report mw5153857.

• Brand Name: TRUSTEEL INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNOMEDICAL A/S
• MDR Report Key: 19115002
• MDR Text Key: 340415734
• Report Number: MW5153858
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/11/2024

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
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ADVIL; CLARITIN ; LEVOTHYROXINE; NOVOLOG; STATIN
• Patient Outcome(s): Life Threatening
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 43 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White