MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC. T:SLIM X2 INSULIN PUMP WITH BASAL-IQ; AUTOMATED INSULIN DOSING , THRESHOLD SUSPEND

Model Number 1005698

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hypoglycemia (1912)

Event Date 04/16/2019

Event Type  malfunction  

Event Description

The patient was being followed by the (b)(6) hospital endocrine clinic for diabetes type i.Her family was using insulin injections as prescribed.3 months later, the endocrine team started discussions with the family about future use of an insulin pump.Before using the insulin pump, the family required several teaching sessions with the diabetes nurse educator per usual process.The insulin pump was ordered from the company for this international patient in january in preparation for future use.The pump is often ordered much ahead of time because of the lengthy insurance/embassy approval process.The pump was delivered to the family home.The father of the patient called the tech support number for the tandem insulin pump the following day and requested guidance via phone support for setting up and applying insulin pump to the pre-school aged patient at home.There were no prescriber orders for insulin pump settings.The endocrine team had no knowledge of the father's plan to start the insulin pump against medical instructions without proper teaching and competency.Somehow, the tech support person gave the father instructions to set up the pump and "install" pump on child's body.The father used inappropriate insulin vial to set up the pump which was the insulin being used previously for subcutaneous injections.There had been no prescription written yet for the appropriate insulin to be used in the future for the pump.That night, the child sustained low blood sugars due to the continuous infusion of basal rate insulin which was incorrectly set-up.The low blood sugars were treated by the parents at home.The next day, the father called the endocrine team to notify them of the low blood sugars.When it was discovered that the father had started the insulin pump incorrectly with the inappropriate guidance of the tandem tech support staff, the parents were instructed to immediately take the insulin pump off the child and return to the previous insulin injections of which they were competent.

• Brand Name: T:SLIM X2 INSULIN PUMP WITH BASAL-IQ
• Type of Device: AUTOMATED INSULIN DOSING , THRESHOLD SUSPEND
• Manufacturer (Section D): TANDEM DIABETES CARE, INC.; 11075 roselle street; san diego CA 92121
• MDR Report Key: 10082591
• MDR Text Key: 191840910
• Report Number: 10082591
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00850006613373
• UDI-Public: 00850006613373
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1005698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2020
• Device Age: 1 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1460 DA