MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM G5 SYSTEM; CONTINUOUS GLUCOSE MONITOR

Model Number 1000096

Device Problems Charging Problem (2892); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2018

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 usb port appeared "different" from when the customer first received the pump, which caused difficulty charging the pump battery.There was no adverse impact to the customer's blood glucose level.Reportedly, the customer continued to use the pump for insulin therapy.

Manufacturer Narrative

The investigation has been completed.Based on the analysis, the alleged malfunction could not be verified; however, a different issue was identified.

• Brand Name: T:SLIM G5 SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• 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: 8183002
• MDR Text Key: 131002135
• Report Number: 3013756811-2018-47099
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00853052007295
• UDI-Public: (01)00853052007295
• 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: 12/19/2018

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 Number: 1000096
• Device Catalogue Number: 1000897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 03/12/2019
• Supplement Dates FDA Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 76 YR