MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC. TANDEM TSLIM CONTROL IQ INSULIN PUMP; INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER

Model Number TSLIM CONTROL IQ INSULIN PUMP

Device Problem Material Twisted/Bent (2981)

Patient Problem Hyperglycemia (1905)

Event Date 02/16/2022

Event Type  Injury  

Event Description

The tandem tslim control iq insulin pump doesn't have warning patients when insulin isn't being delivered.This happened to me today resulting in a blood sugar of over 400; although the pump said i still had adequate insulin on board.It was very scary to me because i didn't know if it was safe to give additional insulin.The problem was a bent canula infusion set, unable to me detected.Generally the tandem tslim pump is poorly designed for users and this is another example of it.Can you make them do focus groups? get better engineers? install a safety alarm when insulin isn't being delivered? thank you.Fda safety report id# (b)(4).

Event Description

The tandem tslim control iq insulin pump doesn't have warning patients when insulin isn't being delivered.This happened to me today resulting in a blood sugar of over 400; although the pump said i still had adequate insulin on board.It was very scary to me because i didn't know if it was safe to give additional insulin.The problem was a bent canula infusion set, unable to me detected.Generally the tandem tslim pump is poorly designed for users and this is another example of it.Can you make them do focus groups? get better engineers? install a safety alarm when insulin isn't being delivered? thank you.Fda safety report id# (b)(4).

• Brand Name: TANDEM TSLIM CONTROL IQ INSULIN PUMP
• Type of Device: INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
• Manufacturer (Section D): TANDEM DIABETES CARE, INC.
• MDR Report Key: 13579001
• MDR Text Key: 285995473
• Report Number: MW5107593
• Device Sequence Number: 1
• Product Code: QJI
• 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: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TSLIM CONTROL IQ INSULIN PUMP
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White