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

Model Number 1001680

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2021

Event Type  Injury  

Event Description

Glucose levels very high; with insulin pump infusion device failed due to cannula folding/bending not allowing subcutaneous infusion of insulin.The pump is by tandem and tandem infusion sets "autosoft 90" and "autosoft xc 90".Fda safety report id# (b)(4).

• Brand Name: AUTOSOFT XC INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNOMEDICAL A/S
• MDR Report Key: 12583331
• MDR Text Key: 275211438
• Report Number: MW5104412
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016620
• UDI-Public: (01)05705244016620(17)240601(10)
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/02/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1001680
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 68