MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number 1000096

Device Problems Pumping Stopped (1503); Battery Problem (2885); Material Deformation (2976)

Patient Problem Hyperglycemia (1905)

Event Date 06/29/2019

Event Type  Injury  

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 pump battery was observed to be depleting rapidly.Subsequently the pump shut down.Additionally, the backside of the pump where the battery is located was observed to have "expanded" and the customer was unable to turn the pump on again.The customer's blood glucose (bg) was 600 mg/dl.The customer declined to provide information regarding how the elevated bg was addressed or the form of alternate insulin therapy that the customer reverted to.

Manufacturer Narrative

The investigation has been completed.Based on the analysis, the alleged battery issue was verified; however, the 'expanded battery' was not verified.Additionally, a different issue was identified (shattered touchscreen).

• 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 Key: 8812313
• MDR Text Key: 151747590
• Report Number: 3013756811-2019-42976
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00853052007981
• UDI-Public: (01)00853052007981
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1000096
• Device Catalogue Number: 1003808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/29/2019
• Initial Date FDA Received: 07/22/2019
• Supplement Dates Manufacturer Received: 09/10/2019
• Supplement Dates FDA Received: 09/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR