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 Filling Problem (1233); Incorrect Measurement (1383)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2020

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 and evaluation is performed.

Event Description

It was reported that a minimum fill notification occurred after the user filled the cartridge with 300 units of insulin during the load sequence.Customer¿s blood glucose level was 348 mg/dl.Information regarding alternate insulin therapy was not provided.

Manufacturer Narrative

Remove: 4582.

• 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: 11084641
• MDR Text Key: 224059206
• Report Number: 3013756811-2020-148788
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00853052007264
• UDI-Public: 00853052007264
• Combination Product (y/n): N
• PMA/PMN Number: K201214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2020

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: 01/07/2021
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 02/20/2021; 02/20/2021
• Supplement Dates FDA Received: 02/23/2021; 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1
• Patient Sequence Number: 1
• Patient Age: 62 YR