MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number 1002717

Device Problems Partial Blockage (1065); Obstruction of Flow (2423)

Patient Problem Hyperglycemia (1905)

Event Date 01/08/2023

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 594-595 mg/dl with high ketones; suspected cause was due to occlusions.A cartridge change was performed to resolve the occlusion issue.Customer delivered a correction bolus via pump to address bg level.Customer was hospitalized; treatment was unknown.A system check was performed, and no issues were identified with the insulin in use at the time of event.Air bubbles were observed in the infusion set tubing; the cartridge connection was noted to be 'slightly loose' and require tightening.Customer experienced lipohypertrophy and was educated by diabetes educator on the impact lipohypertrophy has on insulin absorption.Multiple attempts were made to follow up with the customer regarding the reported issue; however, no response from the customer was received.No additional patient or event information was available.

• Brand Name: T:SLIM X2 INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle street; san diego CA 92121
• Manufacturer Contact: michael trier ; 8584011451
• MDR Report Key: 16280843
• MDR Text Key: 308606531
• Report Number: 3013756811-2023-11849
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P140015
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1002717
• Device Catalogue Number: 1002684-A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2019
• 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: INFUSION SET: TRUSTEELINSULIN TYPE: NOVOLOG/NOVOR
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Ethnicity: Non Hispanic