• 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 Problems Filling Problem (1233); Incorrect Measurement (1383); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/02/2022
Event Type  malfunction  
Manufacturer Narrative
The device has been received for evaluation; however, device evaluation is not yet complete. A supplemental report will be submitted upon completion of the evaluation.
 
Event Description
It was reported that an occlusion alarm occurred. It was reported that an occlusion alarm occurred. During a pump system check, a new cartridge was loaded, and a minimum fill notification was received and a pump air leak was detected. The customers blood glucose level was 159 mg/dl. A replacement pump was sent to the customer to resolve the issue, the customer will use manual dose injection for insulin therapy.
 
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 Key14205475
MDR Text Key290058014
Report Number3013756811-2022-40649
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,Followup
Report Date 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1000096
Device Catalogue Number1000886
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2022
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received05/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2019
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: 04/26/2022 Patient Sequence Number: 1
Treatment
INFUSION SET: AUTOSOFT XCINSULIN TYPE: NOVOLOG /
-
-