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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 Problems Charging Problem (2892); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/25/2019
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 usb cable could not be inserted into the usb port to charge the pump.There was no reported adverse impact to the customer's blood glucose level.Reportedly, the customer reverted to alternate therapy for diabetes management.
 
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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
mick trier
san diego, CA 92121
8584011451
MDR Report Key9291813
MDR Text Key165584848
Report Number3013756811-2019-79184
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 distributor
Type of Report Initial,Followup
Report Date 11/07/2019
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 Manufacturer11/14/2019
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 10/31/2019
Initial Date FDA Received11/07/2019
Supplement Dates Manufacturer Received11/18/2019
Supplement Dates FDA Received11/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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