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 Problems Abdominal Pain (1685); Hyperglycemia (1905); Tachycardia (2095)

Event Date 09/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Per tandem¿s t:slim x2 g6 user guide: ¿do not use any other insulin with your system other than u-100 humalog or u-100 novolog.Only humalog and novolog have been tested and found to be compatible for use in the system." (b)(4).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 592 mg/dl and large ketones (diabetic ketoacidosis).The cause of elevated bg was unknown.Reportedly, customer experienced weakness, stomach pain, vomiting, and a rapid heart rate.The customer went to the emergency room and was subsequently hospitalized.Bg was treated with manual insulin injection, potassium chloride, intravenous fluids, and medication to treat heart rate, vomiting, and pain.Reportedly, the customer was released on (b)(6) 2019 with the issue resolved and no permanent damage.Tandem technical support (cts) performed system check with customer and verified that pump and supplies were functioning as intended.Reportedly, the customer was using admelog insulin.Cts educated the customer on insulin labeling.Customer acknowledged.

• 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: 9207884
• MDR Text Key: 162836812
• Report Number: 3013756811-2019-71028
• 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: 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1000096
• Device Catalogue Number: 1000103
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2017
• 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: ADMELOG. INFUSION SET: AUTOSOFT 30.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 17 YR
• Patient Weight: 46