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

Device Problem Inaccurate Delivery (2339)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2021

Event Type  Injury  

Event Description

Tandem t-slim x2 with control iq gives unannounced insulin boluses.I am not alerted to the bolus nor am aware it is "on board".There is no indication from the pump that it has just administered insulin.In my case i do not need the auto-correct bolus and it drives my blood sugar low.See attached screenshot.Fda safety report id # (b)(4).

• Brand Name: TANDEM T-SLIM X2 INSULIN PUMP WITH CONTROL IQ
• Type of Device: INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
• Manufacturer (Section D): TANDEM DIABETES CARE, INC.
• MDR Report Key: 12583299
• MDR Text Key: 275226768
• Report Number: MW5104410
• Device Sequence Number: 1
• Product Code: QJS
• 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: 10/01/2021

1 Device was Involved in the Event

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
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 80