MAUDE Adverse Event Report: UNOMEDICAL A/S AUTO SOFT XC; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Failure to Deliver (2338); Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 05/28/2022

Event Type  malfunction  

Event Description

Using tandem t:slim auto soft xc experienced diabetic keto acidosis dka due to cannula being inserted and crimped or bent preventing proper insulin delivery.This occurred again on (b)(6) 2022.This is the second time in two weeks since switching from medtronic insertion devices that never caused this issue.Tandem auto soft xc.Fda safety report id# (b)(4).

• Brand Name: AUTO SOFT XC
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNOMEDICAL A/S
• MDR Report Key: 14633205
• MDR Text Key: 293698559
• Report Number: MW5110194
• 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: 06/05/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: TANDEM T:SLIM X2
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White