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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 1000354
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 03/09/2021
Event Type  Injury  
Manufacturer Narrative
Device not returned.
 
Event Description
It was reported that the customer did not consume food in time for the intended amount of bolus delivered. The customer's blood glucose (bg) level subsequently decreased to range from 29-101 mg/dl resulting in the customer losing consciousness. Customer consumed carbohydrates and stopped insulin deliveries to address bg. Additionally, emergency medical technicians (emts) administered intravenous glucose/d5/glucagon to treat the low bg. Recommendation was made to consult with healthcare provider regarding diabetes management.
 
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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 Key11590809
MDR Text Key242988303
Report Number3013756811-2021-39380
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
Report Date 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1000354
Device Catalogue Number1000897
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 Received03/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2018
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: 03/30/2021 Patient Sequence Number: 1
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