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

Model Number 1000096

Device Problem Pumping Stopped (1503)

Patient Problem No Patient Involvement (2645)

Event Date 10/10/2020

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 turned on the pump for the first time in approximately 1.5 years and subsequently a malfunction alarm occurred.During troubleshooting with tandem technical support, the malfunction alarm was cleared, and insulin delivery was resumed successfully.Customer¿s blood glucose level was 114 mg/dl.

• 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
• MDR Report Key: 10778034
• MDR Text Key: 214374433
• Report Number: 3013756811-2020-119227
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00853052007257
• UDI-Public: (01)00853052007257
• Combination Product (y/n): N
• PMA/PMN Number: P140015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1000096
• Device Catalogue Number: 1000885
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR