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

Model Number 1002717

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.Per the user guide: always twist the luer-lock connection between the cartridge tubing and the infusion set tubing an extra quarter of a turn to ensure a secure connection.A loose connection can cause insulin to leak, resulting in under delivery of insulin.This can cause high blood glucose.

Event Description

It was reported that the cartridge and infusion set luer lock became disconnected.Customer's blood glucose (bg) was 486 mg/dl and manual insulin injection was administered to address bg.Customer reconnected luer lock to resolve the issue and insulin delivery was resumed.

• 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 Key: 10036351
• MDR Text Key: 190318227
• Report Number: 3013756811-2020-44152
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/07/2020

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: 1002717
• Device Catalogue Number: 1002684
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/16/2020
• Initial Date FDA Received: 05/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2019
• 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 Age: 22 YR