• 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 1000354
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Head Injury (1879); Hypoglycemia (1912)
Event Date 06/13/2022
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 blood glucose (bg) level of 25 mg/dl, and a fall causing customer to sustain a head injury requiring stitches. The cause of the low bg was unknown, however, customer was reportedly a brittle diabetic. The customer went to the emergency room and was subsequently hospitalized in the intensive care unit. Bg was treated with intravenous saline. Reportedly, the customer was released on (b)(6) 2022 with the issue resolved and no permanent damage.
 
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 Key15055276
MDR Text Key296165513
Report Number3013756811-2022-72946
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 06/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number1000354
Device Catalogue Number1006379
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received06/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2021
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: 07/19/2022 Patient Sequence Number: 1
-
-