MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY; AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND

Model Number 1000096

Device Problems Loose or Intermittent Connection (1371); Charging Problem (2892); Device Sensing Problem (2917); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

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 wake button was intermittently unresponsive.At the time of the reported with tandem technical support, the button was operating as intended.Additionally, it was reported that the usb port was damaged and the customer intermittently experienced difficulty plugging a cable into the usb port.Reportedly, customer was still able to successfully charge the pump and continued to use the pump for insulin therapy.There was no impact to the customer's blood glucose level.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information was received from the customer reporting that the pump could not be charged properly without the customer maneuvering the cable into the charging port at a certain angle.H6: added device code 1371 and 2892.

• Brand Name: T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
• Type of Device: AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND
• Manufacturer (Section D): TANDEM DIABETES CARE; 11075 roselle street; san diego CA 92121
• MDR Report Key: 10416371
• MDR Text Key: 203300539
• Report Number: 3013756811-2020-83361
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00853052007264
• UDI-Public: 00853052007264
• Combination Product (y/n): N
• PMA/PMN Number: P180008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2020

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: 1000886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/25/2020
• Initial Date FDA Received: 08/17/2020
• Supplement Dates Manufacturer Received: 08/18/2020; 10/08/2020
• Supplement Dates FDA Received: 08/19/2020; 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 80