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

Model Number 1000354

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

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 12/13/2020

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.Per tandem¿s t:slim x2 g6 pump user guide states: "you tapped stop insulin in the options menu and insulin delivery has been stopped for more than 15 minutes." per tandem¿s t:slim x2 g6 user guide: "if you start to program a bolus, but do not complete the request within 90 seconds, the incomplete bolus alert occurs.You are prompted to return to the bolus screen to complete the request.".

Event Description

It was reported that the customer was hospitalized due to a blood glucose (bg) level ranging from 515-572 mg/dl and diabetic ketoacidosis.Customer was treated with intravenous insulin and saline, and was released from the hospital on (b)(6) 2020 with the issue resolved and no permanent damage.Reportedly, the customer received an incomplete bolus alert after attempting to deliver a bolus.Additionally, a resume pump alarm occurred due to the customer not resuming insulin delivery after the pump was charged.Tandem technical support educated the customer on incomplete bolus alerts and resume pump alarms.Customer understood and acknowledged that the pump performed 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: 11088978
• MDR Text Key: 224114394
• Report Number: 3013756811-2020-150234
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00850006613731
• UDI-Public: 00850006613731
• 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: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1000354
• Device Catalogue Number: 1006379
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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; Required Intervention
• Patient Age: 9 YR
• Patient Weight: 35