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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 Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Nausea (1970)
Event Date 10/28/2019
Event Type  Injury  
Manufacturer Narrative
No product was returned for evaluation. Should new relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the customer was hospitalized due to an elevated blood glucose (bg) level of greater than 500 mg/dl, along with a hypertensive crisis, intractable nausea and vomiting, as well as elevated troponin; cause was unknown. Customer attempted to address bg by delivering a bolus. While in the hospital, the customer was treated with an insulin drip. The customer was discharged on 10/31/2019 with no permanent damage. System check with tandem technical support confirmed that the pump and related supplies were functioning as intended. The customer was instructed to consult with the healthcare provider regarding bg level.
 
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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 Key9343869
MDR Text Key167050175
Report Number3013756811-2019-80867
Device Sequence Number1
Product Code OZO
UDI-Device Identifier00853052007301
UDI-Public(01)00853052007301
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 company representative
Reporter Occupation
Type of Report Initial
Report Date 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1000096
Device Catalogue Number1000898
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received10/31/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2019
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: 11/19/2019 Patient Sequence Number: 1
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