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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
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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 Problem Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/01/2019
Event Type  malfunction  
Manufacturer Narrative
No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.Device not returned.
 
Event Description
It was reported multiple cartridges were damaged; cause was unknown.Reportedly, customer wears the pump in a belt.No reported adverse impact to the customer's blood glucose.
 
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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
Manufacturer Contact
julia kensick
11075 roselle st.
san diego, CA 92121
8583666900
MDR Report Key8380550
MDR Text Key137732007
Report Number3013756811-2019-10286
Device Sequence Number1
Product Code OYC
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
P140015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/28/2019
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 Manufacturer08/20/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 02/07/2019
Initial Date FDA Received02/28/2019
Supplement Dates Manufacturer Received08/27/2019
Supplement Dates FDA Received08/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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