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 Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2021

Event Type  malfunction  

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 a cartridge did not fit onto the pump.A cartridge change was performed resolving the issue.There was no reported impact to customer¿s blood glucose level.

• 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: mick trier ; san diego, CA 92121 ; 8584011451
• MDR Report Key: 12657618
• MDR Text Key: 277181322
• Report Number: 3013756811-2021-113632
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• PMA/PMN Number: P140015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1002717
• Device Catalogue Number: 1002684-D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/19/2021
• 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