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

Model Number 004628-005

Device Problems False Alarm (1013); Improper Flow or Infusion (2954)

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

Event Date 05/05/2022

Event Type  malfunction  

Event Description

It was reported that the pump was not delivering boluses as intended.Additionally, it was reported that false occlusion alarms occurred.There was no reported impact to the customer's blood glucose level.No additional information was provided and the customer declined troubleshooting with tandem technical support.

Manufacturer Narrative

No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.

• Brand Name: T:FLEX INSULIN DELIVERY SYSTEM
• Type of Device: INFUSION PUMP
• 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: 14488770
• MDR Text Key: 292515094
• Report Number: 3013756811-2022-51684
• 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: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• 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
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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: 21 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic