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

Model Number 4628-003

Device Problems Out-Of-Box Failure (2311); Inappropriate or Unexpected Reset (2959)

Patient Problem No Patient Involvement (2645)

Event Date 08/27/2017

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.Device not returned.

Event Description

It was reported that the pump reset unexpectedly.There was no patient involvement, as the issue occurred during setup of the pump and had not been used on the customer at the time of the event.Reportedly, the pump resumed operation.

• Brand Name: T:SLIM G4 SYSTEM
• Type of Device: INSULIN PUMP
• Manufacturer (Section D): TANDEM DIABETES CARE; 11045 roselle street; san diego CA 92121
• Manufacturer Contact: julia kensick ; 11045 roselle st.; san diego, CA 92121 ; 8583666900
• MDR Report Key: 6876340
• MDR Text Key: 86616046
• Report Number: 3007981285-2017-26914
• 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
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• 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: 007829
• Other Device ID Number: (01)852162004439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 16 YR