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

Model Number 4628-003

Device Problems Pumping Stopped (1503); Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2016

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 a malfunction alarm occurred and the pump stopped all insulin delivery.There was no impact to the customer's blood glucose level.Subsequently, it was noted that although the pump was able to beep and vibrate, it was otherwise unresponsive.It was indicated that the customer would use manual injections as alternate insulin therapy.

Manufacturer Narrative

(b)(4).

• 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: 5975049
• MDR Text Key: 55564160
• Report Number: 3007981285-2016-10794
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• 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: 006194
• Other Device ID Number: (01)00852162004408(21)483884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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: 42 YR