Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
  • 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; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR Back to Search Results
Model Number 1002717
Device Problems Partial Blockage (1065); Insufficient Flow or Under Infusion (2182)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2020
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned; however, the device has not yet been received.A supplemental report will be submitted if the device is received.
 
Event Description
It was reported that the customer believed that the pump was not delivering insulin strongly enough/fast enough.Additionally, it was reported that air bubbles were observed.Customer's blood glucose level ranged between 198-361 mg/dl.Reportedly, supply changes were performed to address the issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
T:SLIM X2 INSULIN PUMP
Type of Device
PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
Manufacturer (Section D)
TANDEM DIABETES CARE
11075 roselle street
san diego CA 92121
MDR Report Key10080980
MDR Text Key191761545
Report Number3013756811-2020-49739
Device Sequence Number1
Product Code OYC
Combination Product (y/n)N
PMA/PMN Number
P140015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 05/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1002717
Device Catalogue Number1002684
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2020
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 05/01/2020
Initial Date FDA Received05/21/2020
Supplement Dates Manufacturer Received09/05/2020
Supplement Dates FDA Received09/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
INSULIN: NOVOLOG/NOVORAPID, INFUSION SET: VARISOFT; INSULIN: NOVOLOG/NOVORAPID, INFUSION SET: VARISOFT
Patient Age47 YR
-
-