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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 1002717
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 11/08/2020
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 experienced a low blood glucose (bg) level of 20 mg/dl. Bg cause was not known. Reportedly, the customer experienced a diabetic seizure and strangers provided assistance in treating the low bg. Customer consumed carbohydrates to address bg. Additionally, the customer was sore and received bruised legs from the event. Recommendation was made to consult with a healthcare provider to discuss 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 Key10915823
MDR Text Key218642882
Report Number3013756811-2020-131387
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 11/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1002717
Device Catalogue Number1005698
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received01/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2020
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: 11/28/2020 Patient Sequence Number: 1
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