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 03/02/2016

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation.Should new relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the customer opened new pump to charge before training when a malfunction alarm occurred.There was no patient involvement, as the pump was not being used on a customer at the time of the reported event.During troubleshooting with tandem technical support, the malfunction alarm was cleared.

• 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: 5524647
• MDR Text Key: 41124540
• Report Number: 3007981285-2016-72796
• 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: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• 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)477817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• 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: 19 YR