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U.S. Department of Health and Human Services

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

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TANDEM DIABETES CARE, INC. T:SLIM X2 INSULIN PUMP WITH BASAL-IQ AUTOMATED INSULIN DOSING , THRESHOLD SUSPEND Back to Search Results
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.
 
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Brand NameT:SLIM X2 INSULIN PUMP WITH BASAL-IQ
Type of DeviceAUTOMATED INSULIN DOSING , THRESHOLD SUSPEND
Manufacturer (Section D)
TANDEM DIABETES CARE, INC.
11075 roselle street
san diego CA 92121
MDR Report Key10082591
MDR Text Key191840910
Report Number10082591
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received05/22/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1005698
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/11/2020
Device Age1 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer05/22/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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