MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Model Number 1002717

Device Problem Obstruction of Flow (2423)

Patient Problems Chest Pain (1776); Vomiting (2144)

Event Date 10/23/2021

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 the customer experienced an elevated blood glucose (bg) level of 324-325 mg/dl, vomiting, chest pain, and a 6.2 mmol/l ketone level resulting in a hospitalization.At the time of the event, the customer had received multiple occlusions.No issues were observed with the cartridge, infusion set cannula, infusion set tubing, or insulin in use at the time of the event; the pump wsas confirmed to be working as intended at the time of the event.A correction bolus was delivered to address the adverse event prior to the hospitalization.While hospitalized, the customer was treated with intravenous saline and insulin.The customer was discharged from the hospital; no release date was confirmed as customer declined to provide this information.

• 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: 12797722
• MDR Text Key: 280692565
• Report Number: 3013756811-2021-119618
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K201214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1002717
• Device Catalogue Number: 1002684-D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• 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
• Treatment: INSULIN: NOVOLOG/NOVORAPID
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Ethnicity: Non Hispanic