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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908)
Event Date 06/07/2020
Event Type  Injury  
Manufacturer Narrative
The tandem pump user guide states, "make sure that you always have an insulin syringe and vial of insulin or a prefilled insulin pen with you as a backup for emergency situations. " the device has been received for evaluation; however, device evaluation is not yet complete. A supplemental report will be filed upon completion of the evaluation.
 
Event Description
It was reported that a continuous glucose monitor (cgm) error 41 occurred on 6/7/2020. Two days later the customer went to the emergency room and was subsequently hospitalized due to an elevated blood glucose (bg) level, high blood pressure, and chest pain; (specific bg value was not provided). Customer had continued to use the pump without an active cgm for insulin therapy and as a result did not adequately manage diabetes properly. A magnetic resonance imaging and a computerized axial tomography scan was performed on the customer, and was treated with intravenous fluids and insulin injections. Treatment received resolved the reported issue, and the customer was released from the hospital on (b)(6) 2020 with no permanent damage.
 
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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
mick trier
san diego, CA 92121
8584011451
MDR Report Key10214547
MDR Text Key197022319
Report Number3013756811-2020-68923
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00853052007325
UDI-Public(01)00853052007325
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 06/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1000096
Device Catalogue Number1000912
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received07/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2020
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: 06/30/2020 Patient Sequence Number: 1
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