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 Insufficient Flow or Under Infusion (2182)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Coma (2417)

Event Date 07/01/2020

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 experienced a blood glucose (bg) level of approximately 600 mg/dl, which was addressed via bolus with pump.However, customer was subsequently hospitalized due to diabetic ketoacidosis, resulting in a diabetic coma.Treatment was administered via intravenous insulin.Reportedly, the customer was released three days later with the issue resolved and no permanent damage.The customer alleged that the pump was not delivering insulin properly; however this could not be confirmed as customer declined a system check with tandem technical support.Customer reverted to manual injections for insulin delivery.

• 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
• MDR Report Key: 10848043
• MDR Text Key: 216554016
• Report Number: 3013756811-2020-126611
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00850006613380
• UDI-Public: 00850006613380
• Combination Product (y/n): N
• PMA/PMN Number: K201214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1002717
• Device Catalogue Number: 1005706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INSULIN TYPE: HUMALOG; INSULIN TYPE: HUMALOG
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR