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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 Hypoglycemia (1912); Injury (2348)
Event Date 02/02/2020
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 went to the emergency room (er) due to a low blood glucose (bg) level of 19 mg/dl, subsequently causing customer to get into a car accident. Cause of elevated bg level was unknown. Bg was treated with glucagon. Reportedly, customer left the er with a minor face injury, however, with customer in stable condition (bg 211 mg/dl).

 
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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 Key9871384
MDR Text Key184642169
Report Number3013756811-2020-29564
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP180008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 03/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/24/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number1000096
Device Catalogue Number1000885
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 Received03/02/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2017
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: 03/24/2020 Patient Sequence Number: 1
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