MAUDE Adverse Event Report: TANDEM DIABETES CARE, INC. TANDEM T SLIM INSULIN PUMP; INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER

Device Problem Communication or Transmission Problem (2896)

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

Event Type  Injury  

Event Description

Patient uses tandem pump with control iq.Patient has reported many instances of signal loss despite wearing pump and cgm adequately.He recently also reported entering carbs into his pump correctly, but then noticing the pump entered hundreds of carbs instead of the amount he entered.Did not have hypoglycemia during this second episode due to ongoing food intake.Patient reports contacting tandem every time an issue occurs, is often sent a new transmitter, but problems continue.Fda safety report id# (b)(4).

• Brand Name: TANDEM T SLIM INSULIN PUMP
• Type of Device: INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
• Manufacturer (Section D): TANDEM DIABETES CARE, INC.
• MDR Report Key: 14193696
• MDR Text Key: 290059860
• Report Number: MW5109285
• Device Sequence Number: 1
• Product Code: QJI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White