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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Palpitations (2467)

Event Date 07/21/2020

Event Type  Injury  

Manufacturer Narrative

The pump user guide states, "tandem diabetes care, inc. Recommends periodically checking the battery level indicator, charging the pump for a short period of time every day (10 to 15 minutes), and also avoiding frequent full discharges. " 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 customer went to the emergency room (er) due to a blood glucose (bg) level of 457 mg/dl, with ketones, and palpitations. It was reported that the battery level depleted until the pump shut down while customer was sleeping. Tandem technical support reviewed the customer¿s settings and usage rates and determined that the battery was depleting at a normal rate. Customer acknowledged. Bg was treated with fluids and an unspecified intravenous treatment. Reportedly, customer left the er 22 hours later with customer in stable condition (bg level not provided).

• 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: 10367161
• MDR Text Key: 201681793
• Report Number: 3013756811-2020-84601
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 1000096
• Device Catalogue Number: 1000886
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 08/05/2020 Patient Sequence Number: 1