MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC. T:CONNECT MOBILE PHONE APP; CONTINUOUS GLUCOSE MONITOR SECONDARY DISPLAY

Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Tandem diabetes released new t:connect ios software that increased insulin pump power use.Tandem diabetes has not notified users of defective software.This report is to urge fda to investigate communication practices of tandem diabetes and require much more transparency.Reference report: mw5152428.

• Brand Name: T:CONNECT MOBILE PHONE APP
• Common Device Name: CONTINUOUS GLUCOSE MONITOR SECONDARY DISPLAY
• Manufacturer (Section D): TANDEM DIABETES CARE, INC.
• MDR Report Key: 18856049
• Report Number: MW5152427
• Device Sequence Number: 20892726
• Product Code: PJT
• UDI-Device Identifier: 90850018992452
• UDI-Public: 90850018992452
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/02/2024

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2024
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INSULIN.; T:SLIM X2 INSULIN PUMP
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White