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 Filling Problem (1233)

Patient Problems Hyperglycemia (1905); Renal Failure (2041); Diabetic Ketoacidosis (2364)

Event Date 02/03/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned; however, the device has not yet been received.A supplemental report will be submitted if the device is received and evaluation is performed.Device not returned.

Event Description

It was reported that insulin drips were not observed to be exiting the infusion set cannula during the load fill tubing process.Reportedly, a supply change was performed to address the issue, however the issue was not resolved.It was reported that the customer's blood glucose was (bg) of 550 mg/dl with diabetic ketoacidosis (dka).Customer administered manual injections to treat elevated bg and dka.Customer was hospitalized on (b)(6) 2021 and was given saline and insulin intravenously to treat elevated bg and dka.Customer was released from the hospital on (b)(6) 2021 with kidney failure.Reportedly customer reverted to an alternate form of insulin therapy.

• 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: 11398633
• MDR Text Key: 234237550
• Report Number: 3013756811-2021-25988
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00853052007264
• UDI-Public: 00853052007264
• 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: 03/02/2021

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?: Yes
• Device Operator: No Information
• Device Model Number: 1000096
• Device Catalogue Number: 1000886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 04/22/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INSULIN: NOVOLOG / NOVORAPID; INSULIN: NOVOLOG / NOVORAPID
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 15 YR