MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 PUMP WITH INTEROPERABLE TECHNOLOGY; ALTERNATE CONTROLLER ENABLED INFUSION PUMP

Model Number 1002717

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoglycemia (1912); Nausea (1970); Shaking/Tremors (2515)

Event Date 12/24/2022

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.Participant id: (b)(4).The associated device has control-iq 1.5b5.0.1 software.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 user administered a mealtime bolus and subsequently forgot to eat the meal.The continuous glucose monitor (cgm) sensor was located on the opposite side of the body from the pump, and no cgm readings were present at the time of the event.However, the user felt nauseous and shaky and concluded that they were experiencing hypoglycemia.Juice was provided by a family member which the user consumed to address the hypoglycemia.Reportedly, the user began feeling better and cgm readings resumed showing 64 mg/dl and a rising trend arrow.

• Brand Name: T:SLIM X2 PUMP WITH INTEROPERABLE TECHNOLOGY
• Type of Device: ALTERNATE CONTROLLER ENABLED INFUSION PUMP
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle street; san diego CA 92121
• Manufacturer Contact: michael trier ; 8584011451
• MDR Report Key: 16215713
• MDR Text Key: 307805207
• Report Number: 3013756811-2023-04197
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• PMA/PMN Number: DEN180058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1002717
• Device Catalogue Number: 1004484
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: INSULIN: LYUMJEV 10 ML VIALS.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White