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 Hyperglycemia (1905)

Event Date 06/29/2019

Event Type  Injury  

Manufacturer Narrative

Per the user guide: ¿check that your connection between the cartridge tubing and the infusion set tubing is tight and secure.¿ the device has been received for evaluation; however, device evaluation is not yet complete.A supplemental report will be filed upon completion of the evaluation.

Event Description

It was reported that due to being blind, customer had to feel around for the usb port and subsequently, may have damaged it.After plugging the usb cable into the port, the battery would not charge.Another ac adapter and cable were used with no success.Customer also reported not to have tightened the luer lock between the cartridge pigtail tubing and infusion set tubing and the 2 became disconnected.Customer reconnected and tightened luer lock.Customer's blood glucose (bg) was 600-700 mg/dl and insulin injections were used to address bg.Due to the battery issue, customer reported to have manual injections to manage insulin therapy.

Manufacturer Narrative

The investigation has been performed and the alleged issue usb issue was verified; however, reported cartridge issue could not be verified as the cartridge was not returned.

• 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: 8812556
• MDR Text Key: 151756016
• Report Number: 3013756811-2019-42154
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00853052007318
• UDI-Public: 00853052007318
• 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: 1000911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• 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: 07/29/2019
• Supplement Dates FDA Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2018
• 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
• Treatment: INFUSION SET: TRUSTEEL, INSULIN: HUMALOG
• Patient Outcome(s): Other
• Patient Age: 60 YR