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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 Vibration (1674)
Patient Problem No Patient Involvement (2645)
Event Date 11/14/2018
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 vibration setting did not work.There was no patient involvement, as device had not yet been used on a customer at the time of the reported event.
 
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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 Key8110991
MDR Text Key128610485
Report Number3013756811-2018-41638
Device Sequence Number1
Product Code OYC
Combination Product (y/n)N
Reporter Country CodeIT
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 11/28/2018
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 Number1002682
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 11/14/2018
Initial Date FDA Received11/28/2018
Supplement Dates Manufacturer Received05/10/2019
Supplement Dates FDA Received05/13/2019
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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