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 Obstruction of Flow (2423)

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

Event Date 12/01/2020

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 an occlusion alarm occurred.Customer's blood glucose was 740 mg/dl.Customer was admitted to the hospital for elevated blood glucose and diabetic ketoacidosis.Customer was treated intravenously with saline and insulin, and was released from the hospital 6 days later with kidney injuries.Multiples attempts were made by tandem technical support to follow up with the customer to complete the system check, but no response was received and no additional information was provided.

Manufacturer Narrative

Customer reportedly continued to use the pump for 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: 11065738
• MDR Text Key: 223410866
• Report Number: 3013756811-2020-146378
• 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,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1000096
• Device Catalogue Number: 1000886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFUSION SET: TRUSTEEL; INFUSION SET: TRUSTEEL
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 74 YR
• Patient Weight: 90