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

Model Number 1000096

Device Problems Disconnection (1171); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

Per tandem¿s t:slim x2g5 user guide: ¿check that your connection between the cartridge tubing and the infusion set tubing is tight and secure.¿ no product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the cartridge connection disconnected while the customer was sleeping.An infusion set change was performed to address the issue.Customer's blood glucose level was in the 400's mg/dl range.

• 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: 7846950
• MDR Text Key: 119267544
• Report Number: 3013756811-2018-32163
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00853052007257534974
• UDI-Public: (01)00853052007257534974
• 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
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• 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: 1000885
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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: AUTOSOFT 90, INSULIN:NOVOLOG
• Patient Age: 50 YR
• Patient Weight: 93