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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 Fainting (1847); Hypoglycemia (1912)
Event Date 12/07/2020
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 experienced a low blood glucose of 44 mg/dl likely due to needing settings adjustments. Customer's low bg caused them to black out while driving and necessitated a trip to the emergency room (er), where customer was treated with fluids and intravenous fluids. Customer was released from the er in stable condition after 4 hours. Tandem technical support advised customer to consult their healthcare provider regarding settings adjustments.
 
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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 Key11047326
MDR Text Key222690733
Report Number3013756811-2020-149455
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201214
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received01/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2019
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: 12/21/2020 Patient Sequence Number: 1
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