MAUDE Adverse Event Report: TANDEM DIABETES CARE T:FLEX INSULIN DELIVERY SYSTEM; INFUSION PUMP

Model Number 004628-005

Device Problem Pumping Stopped (1503)

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

Event Date 04/17/2023

Event Type  malfunction  

Event Description

It was reported that the pump shut off unexpectedly.There was no reported adverse impact to the customer's blood glucose level.Customer declined to troubleshoot with tandem technical support, therefore no additional information could be obtained.

Manufacturer Narrative

No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.H3 other text : device not returned.

• Brand Name: T:FLEX INSULIN DELIVERY SYSTEM
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): TANDEM DIABETES CARE; 12400 high bluff drive; san diego CA 92130
• Manufacturer Contact: michael trier ; san diego, CA 92130 ; 8584011451
• MDR Report Key: 16895850
• MDR Text Key: 314833559
• Report Number: 3013756811-2023-63437
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 00852162004569
• UDI-Public: (01)00852162004569
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143189
• 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: 05/09/2023

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 Model Number: 004628-005
• Device Catalogue Number: 007473
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2021
• 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 Age: 27 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic