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 Hyperglycemia (1905); Myocardial Infarction (1969)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.The tandem pump user guide states that a low insulin alert is displayed when there are 5 or less units of insulin in the pump, requesting that the cartridge be changed or pump will stop all deliveries.The alert will continue until the cartridge has been changed; otherwise the pump will stop all insulin deliveries, due to an empty cartridge.In addition, the user guide states: your t:slim pump can stop insulin delivery and alert you (or whoever is with you) if there has been no interaction with the pump within a specified period of time.The default for this alarm is preset to 12 hours.You can set it anywhere between 5 and 24 hours, or off.This alarm notifies you that there has been no interaction with the pump in the specified number of hours and the pump will shut down after 30 seconds.

Event Description

It was reported that the customer was admitted to hospitalization with a blood glucose (bg) of 1300 mg/dl and possible heart attack.Treatment was administered via insulin drip.Review of pump data by tandem technical support revealed multiple low insulin alerts that were not addressed by the customer, and an empty cartridge alarm.In addition, an auto off alarm was also noted.Per pump data, the auto off alarm had been manually set to 5 hours and the customer had not interacted with the pump within 5 hours of the alarm.No additional information was provided.

• 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: 10171101
• MDR Text Key: 195649701
• Report Number: 3013756811-2020-60325
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• 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: 1000886
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2019
• 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: 75 YR