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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

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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 Pumping Stopped (1503)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/03/2021
Event Type  malfunction  
Manufacturer Narrative
The device has been received for evaluation; however, device evaluation is not yet complete. A supplemental report will be filed upon completion of the evaluation.
 
Event Description
It was reported that cartridge alarms intermittently occurred during basal delivery with multiple cartridges. Customer's blood glucose level was 400 mg/dl. Reportedly, the customer reverted to manual injections for insulin therapy.
 
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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 Key11230105
MDR Text Key228688208
Report Number3013756811-2021-08215
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 01/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1000096
Device Catalogue Number1000886
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received03/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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