MAUDE Adverse Event Report: TANDEM DIABETES CARE T:SLIM X2 INSULIN PUMP

Model Number 1000096

Device Problems Device Operates Differently Than Expected (2913); Device Sensing Problem (2917); Inappropriate or Unexpected Reset (2959)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2018

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 while the customer tried to upload the pump to t:connect, the pump had a "screeching noise" and then the customer was unable to do anything with the pump.Reportedly, the pump touchscreen was stuck on a screen.During troubleshooting, tandem's technical support intentionally had the customer trigger a button alarm and customer reported that the pump had been reset.There was no impact to blood glucose.The cartridge was reloaded to address the event and insulin delivery was resumed.

• Brand Name: T:SLIM X2 INSULIN PUMP
• Type of Device: INSULIN PUMP
• 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: 7657299
• MDR Text Key: 113425257
• Report Number: 3013756811-2018-23022
• Device Sequence Number: 1
• Product Code: LZG
• 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: Patient
• Type of Report: Initial
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• 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: 1000103
• Other Device ID Number: (01)00852162004781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• 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: 14 YR
• Patient Weight: 57