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

Model Number 1002717

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 05/18/2020

Event Type  Injury  

Manufacturer Narrative

Per the tandem user guide: do not start to use your pump before consulting with your healthcare provider to determine which features are most appropriate for you.Only your healthcare provider can determine and help you adjust your basalrate(s), carb ratio(s), correction factor(s), target bg, and duration of insulin action.In addition, only your healthcare provider can determine your cgm settings and how you should use your sensor trend information to help you manage your diabetes.Incorrect settings can result in over delivery or under delivery of insulin.This can cause hypoglycemia (low bg) or hyperglycemia (high bg) events.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 experienced a blood glucose (bg) level of over 1000mg/dl, hyperkalemia, cardiac arrest, and diabetic ketoacidosis.Reportedly, the customer did not consult with healthcare provider about basal rate settings, and also reported not delivering bolus insulin when needed.Subsequently, customer was hospitalized.Bg was treated with intravenous insulin, and fluids.Customer required resuscitation from cardiac arrest.Reportedly, the customer was released on (b)(6) 2020 with the issue resolved and no permanent damage.

• 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: 10349701
• MDR Text Key: 201171928
• Report Number: 3013756811-2020-79709
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00085006613373
• UDI-Public: 0085006613373
• 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: Other
• Type of Report: Initial
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1002717
• Device Catalogue Number: 1005698
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2020
• 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 Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 35 YR