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

Model Number 4628-003

Device Problem Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation; however, device evaluation is not yet complete.A supplemental report will be filed upon completion of the evaluation.

Event Description

It was reported that a malfunction alarm occurred.There was no patient involvement, as the issue occurred during setup of the pump and had not yet been used on the customer at the time of the reported event.

• Brand Name: T:SLIM G4 SYSTEM
• Type of Device: INSULIN PUMP
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle st; san diego CA 92121
• Manufacturer Contact: julia kensick ; 11045 roselle st.; san diego, CA 92121 ; 8583666900
• MDR Report Key: 5526214
• MDR Text Key: 41166366
• Report Number: 3007981285-2016-73172
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2016
• 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)488842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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: 40 YR