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

Model Number 004628

Device Problems Material Frayed (1262); Pumping Stopped (1503)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned; however, the device has not yet been received.A supplemental report will be submitted if the device is received.

Event Description

It was reported that a malfunction alarm occurred after the pump was taken out of storage mode.Additionally, it was reported that the usb cable was damaged and wires were visible.There was no patient involvement as the customer was not using the pump for insulin therapy.Reportedly, customer reverted to manual injections for insulin therapy.

Manufacturer Narrative

The failure investigation has been completed and the alleged malfunction issue was verified.Based on the analysis, the alleged usb cable issue could not be verified.

• Brand Name: T:SLIM INSULIN DELIVERY SYSTEM
• Type of Device: INSULIN PUMP
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle street; san diego CA 92121
• Manufacturer Contact: mick trier ; san diego, CA 92121 ; 8584011451
• MDR Report Key: 10139211
• MDR Text Key: 194780592
• Report Number: 3013756811-2020-57619
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 00852162004552
• UDI-Public: (01)00852162004552
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 004628
• Device Catalogue Number: 007264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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: 15 YR