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U.S. Department of Health and Human Services

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

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TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND Back to Search Results
Model Number 1000096
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Seizures (2063); Loss of consciousness (2418)
Event Date 02/13/2019
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned; however, the device has not yet been received. A supplemental report will be submitted if the device is received.
 
Event Description
It was reported that the customer's blood glucose (bg) was 70 mg/dl. Customer lost consciousness and had a seizure. Customer was admitted to the hospital. Glucagon and intravenous fluids were administered. Low bg was resolved and customer was discharged on (b)(6) 2019 with no permanent injury. Customer initially alleged that the basal iq did not suspend insulin and was cause of low bg. Tandem technical support reviewed the bolus delivery and basal iq suspension in the pump data. No issues were identified and customer acknowledged that basal iq had suspended appropriately. However, the customer and healthcare provider maintained there was an issue with the pump bolus delivery. Customer reverted to using manual injections for insulin delivery.
 
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Brand NameT:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
Type of DeviceAUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
Manufacturer Contact
julia kensick
11075 roselle st.
san diego, CA 92121
8583666900
MDR Report Key8395008
MDR Text Key137971749
Report Number3013756811-2019-11452
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P180008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1000096
Device Catalogue Number1000885
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received04/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/06/2019 Patient Sequence Number: 1
Treatment
INFUSION SET: AUTOSOFT 90, INSULIN: NOVOLOG
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