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 Excess Flow or Over-Infusion (1311)

Patient Problems Abrasion (1689); Hypoglycemia (1912); Seizures (2063)

Event Date 07/25/2020

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 the customer went to the emergency room (er) due to blood glucose (bg) level ranging from 16-33 mg/dl, and a seizure causing abrasions. Customer alleged that the pump delivered 24 units of insulin, when customer was attempting to correct for 24 grams of carbohydrates consumed. Pump data review confirmed the pump was functioning as intended as data shows customer requested 24 units of insulin, and did not enter a carbohydrate amount. Additionally, customer's max hourly bolus rate was set to 25 grams, so customer would not have received a warning message; however customer maintained that pump was not functioning as intended. Bg was treated with carbohydrates, and an unspecified intravenous treatment. Reportedly, customer left the emergency room 3-4 hours later with customer in stable condition (bg in the 200's mg/dl).

• 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: 10832919
• MDR Text Key: 216090141
• Report Number: 3013756811-2020-126606
• Device Sequence Number: 1
• Product Code: OZO
• 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

• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1000096
• Device Catalogue Number: 1000911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 12/18/2020
• 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: 11/12/2020 Patient Sequence Number: 1