MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM G5 SYSTEM; CONTINUOUS GLUCOSE MONITOR

Model Number 1000096

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Rash (2033)

Event Date 10/01/2018

Event Type  Injury  

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 the customer's healthcare provider alleged the pump was "infected" as the customer experienced intermittent skin irritation/rashes at the infusion set site when the supplies would be changed.The hcp declined tandem clinical diabetes specialist offer to troubleshoot.The type of infusion set use was not provided.

• Brand Name: T:SLIM G5 SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• 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: 8046598
• MDR Text Key: 126398809
• Report Number: 3013756811-2018-39659
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00853052007318
• UDI-Public: 00853052007318
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1000096
• Device Catalogue Number: 1000911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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 Outcome(s): Other
• Patient Age: 22 YR