MAUDE Adverse Event Report: UNOMEDICAL DEVICES SA. DE C.V. TANDEM DIABETES AUTOSOFT XC INFUSION SET; SET, ADMINISTRATION

Model Number AUTOSOFT XC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Pain (1994)

Event Date 09/28/2018

Event Type  Injury  

Event Description

I switched from a medtronic insulin pump to tandem.The iv sets are made by the same company.Unomedical but i am having severe site pain and high blood sugars that i've never had with medtronic or animas.I've contacted tandem but they have no idea what the problem is.I found a blog on the internet where a lot of people are having the same issue.

• Brand Name: TANDEM DIABETES AUTOSOFT XC INFUSION SET
• Type of Device: SET, ADMINISTRATION
• Manufacturer (Section D): UNOMEDICAL DEVICES SA. DE C.V.
• MDR Report Key: 8164963
• MDR Text Key: 130537011
• Report Number: MW5082153
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016958
• UDI-Public: (01)05705244016958(17)210101(10)
• 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: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2021
• Device Model Number: AUTOSOFT XC
• Device Catalogue Number: 1001729
• Device Lot Number: 5221000
• 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): Life Threatening; Other; Disability
• Patient Age: 61 YR
• Patient Weight: 88