MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC. TANDEM X2 SLIM CONTROL IQ; INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER

Model Number X2 SLIM

Device Problems Complete Blockage (1094); Material Puncture/Hole (1504); Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2020

Event Type  malfunction  

Event Description

I am type 1 diabetic wear tandem x2 slim control iq pump, on my flight form (b)(6) to (b)(6) pump stopped insulin deliveries and flashed altitude error.On their website there is no warning or what to do if you fly.Called up tandem and came to know because of pressure this happened and the 6 small holes in the back got blocked.They should have this warning in red and how to prevent it from happening.Fda safety report id# (b)(4).

• Brand Name: TANDEM X2 SLIM CONTROL IQ
• Type of Device: INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
• Manufacturer (Section D): TANDEM DIABETES CARE, INC.
• MDR Report Key: 11093608
• MDR Text Key: 224561561
• Report Number: MW5098561
• Device Sequence Number: 1
• Product Code: QJI
• 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: 12/25/2020

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: No Information
• Device Model Number: X2 SLIM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 66