• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Seizures (2063); Loss of consciousness (2418)
Event Date 03/20/2020
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 diabetic seizure, and loss of consciousness. Blood glucose level not provided. Reportedly, the cause was unknown, however customer was reportedly running low on insulin. The customer went to the emergency room and was subsequently hospitalized. Tandem technical support attempted to obtain additional information with the customer, however, customer was not conscious during event and was therefore unable to provide additional information regarding the issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9948592
MDR Text Key187212665
Report Number3013756811-2020-35663
Device Sequence Number1
Product Code OZO
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 04/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1000096
Device Catalogue Number1000886
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 Received03/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2019
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: 04/10/2020 Patient Sequence Number: 1
-
-