MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM G4 SYSTEM; INSULIN PUMP

Model Number 4628-003

Device Problems Invalid Sensing (2293); Inappropriate or Unexpected Reset (2959)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned; however, the device has not yet been received.A supplemental report will be submitted if the device is received.Device not returned.

Event Description

It was reported that the wake button stopped functioning as intended.During troubleshooting with tandem technical support, the customer confirmed the pump still turned on when plugged into a power source.In addition, it was reported that the pump intermittently unexpectedly reset.There was no reported impact to customer's blood glucose level.Customer had a back up pump for insulin therapy.

• Brand Name: T:SLIM G4 SYSTEM
• Type of Device: INSULIN PUMP
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle street; san diego CA 92121
• Manufacturer Contact: julia kensick ; 11075 roselle st.; san diego, CA 92121 ; 8583666900
• MDR Report Key: 7602337
• MDR Text Key: 111350500
• Report Number: 3013756811-2018-20657
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4628-003
• Device Catalogue Number: 008114
• Other Device ID Number: (01)852162004439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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: 20 YR