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

Model Number 1000096

Device Problems Material Separation (1562); Fitting Problem (2183); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

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 the cartridges are becoming more difficult to insert and remove from her pump.It was also reported that a cartridge was damaged when attempting to remove the cartridge.In addition, it was reported that resistance was felt when filling the cartridge during the load sequence.Customer was able to fill the cartridge with the existing needle and cartridge.The customer's blood glucose level ranged 120-355 mg/dl.Customer continued using the pump for insulin therapy.

Manufacturer Narrative

The failure investigation has been completed.Based on the analysis, the alleged hardware issue could not be verified.The alleged fill resistance and damaged cartridge issue could not be verified due to the cartridge not being returned for investigation.

• 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: 10607097
• MDR Text Key: 209186567
• Report Number: 3013756811-2020-110670
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00853052007295
• UDI-Public: (01)00853052007295
• 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: 09/30/2020

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: 1000897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 11/07/2020
• Supplement Dates FDA Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR