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 Use of Device Problem (1670)

Patient Problem Hyperglycemia (1905)

Event Date 11/29/2020

Event Type  Injury  

Manufacturer Narrative

Per tandem user guide: 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.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 received an auto-off alarm.The customer's blood glucose level was high with moderate ketones.Elevated blood glucose was address with manual injection.Review of the pump data logs verified that the customer did not interact with the pump within 12 hours of the alarm.Tandem technical support educated the customer on the pump's auto-off safety feature per user guide and advised the customer to consult with healthcare provider prior to modifying the setting.

• 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: 11064117
• MDR Text Key: 223358460
• Report Number: 3013756811-2020-146565
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00853052007301
• UDI-Public: (01)00853052007301
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201214
• 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: 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: 1000898
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/11/2020
• 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): Other
• Patient Age: 52 YR