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

Model Number 004628

Device Problems Incorrect Measurement (1383); Failure to Sense (1559)

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

Event Date 05/01/2023

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 the pump touch screen was unresponsive and that the battery was fluctuating.Customer declined to troubleshoot the issue with tandem technical support; therefore the allegation could not be confirmed.

• Brand Name: TANDEM T:SLIM INSULIN DELIVERY SYSTEM
• Type of Device: INSULIN 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: 16986466
• MDR Text Key: 315787671
• Report Number: 3013756811-2023-70151
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 00852162004521
• UDI-Public: (01)00852162004521
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111210
• 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: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 004628
• Device Catalogue Number: 004889
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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: 22 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic