• 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 Problem Palpitations (2467)
Event Date 07/21/2020
Event Type  Injury  
Manufacturer Narrative
The pump user guide states, "tandem diabetes care, inc. Recommends periodically checking the battery level indicator, charging the pump for a short period of time every day (10 to 15 minutes), and also avoiding frequent full discharges. " 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 blood glucose (bg) level of 457 mg/dl, with ketones, and palpitations. It was reported that the battery level depleted until the pump shut down while customer was sleeping. Tandem technical support reviewed the customer¿s settings and usage rates and determined that the battery was depleting at a normal rate. Customer acknowledged. Bg was treated with fluids and an unspecified intravenous treatment. Reportedly, customer left the er 22 hours later with customer in stable condition (bg level not provided).
 
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 Key10367161
MDR Text Key201681793
Report Number3013756811-2020-84601
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 08/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2020
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 Received07/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2018
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: 08/05/2020 Patient Sequence Number: 1
-
-