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

Catalog Number 1002835

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 06/03/2023

Event Type  malfunction  

Event Description

I have a tandem insulin pump.I use trusteel infusion sets.On saturday i opened a new box of infusion sets from a different order/lot and noticed that the tubing felt smoother than usual.About a half hour after the tubing fell out of the connector to the cartridge (like the tubing was not glued to the piece that twists into the connector).This is dangerous because if i had not noticed right away i would not have been getting insulin for an unknown time.Ref: 1002835 , lot: 5397741, manufacturing date: 2022-09-01, expiration date: 2025-08-01.

• Brand Name: TRUSTEEL INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): TANDEM DIABETES / UNOMEDICAL A/S
• MDR Report Key: 17086222
• MDR Text Key: 316858937
• Report Number: MW5118262
• 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: 06/06/2023

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 Operator: Lay User/Patient
• Device Catalogue Number: 1002835
• Device Lot Number: 5397741
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2023
• Patient Sequence Number: 1
• Treatment: DEXCOM G6; NOVOLOG INSULIN; TANDEM INSULIN PUMP +INFUSION SITE AND CARTRIDGE
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian, White