MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Model Number 1000096

Device Problem Mechanical Problem (1384)

Patient Problems Chest Pain (1776); Hyperglycemia (1905); Vomiting (2144)

Event Date 05/31/2021

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified cartridge alarm occurred during insulin deliver.Customer went to the emergency room with vomiting, chest pain and a blood glucose value of 500 mg/dl and ketones, and was subsequently hospitalized customer was treated with intravenous saline and insulin.Customer was discharged 2 days later with the issue resolved.Tandem technical support did a full pump system check and confirmed that pump was functioning as intended.

• Brand Name: T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
• Type of Device: AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
• 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: 12174551
• MDR Text Key: 261736793
• Report Number: 3013756811-2021-75420
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00853052007264
• UDI-Public: 00853052007264
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201214
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1000096
• Device Catalogue Number: 1000886
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: INSULIN: NOVOLOG/ NOVORAPID
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR