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); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2022

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation; however, device evaluation is not yet complete.A supplemental report will be submitted upon completion of the evaluation.

Event Description

It was reported that a minimum fill notification occurred after the user filled the cartridge with 100 units of insulin during the load sequence.A new cartridge was loaded to resolve the issue.Reportedly, customer then received cartridge change errors occurred with multiple cartridges during the load sequence and reported that a cartridge did not fit onto the pump.The customer did not have an alternate method of insulin therapy available but declined follow up from tandem technical support to confirm an alternative method of insulin therapy was obtained.Customer¿s blood glucose level was 296 mg/dl.

• 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
• Manufacturer Contact: mick trier ; san diego, CA 92121 ; 8584011451
• MDR Report Key: 14515752
• MDR Text Key: 293091370
• Report Number: 3013756811-2022-51767
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00853052007264
• UDI-Public: 00853052007264
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201214
• 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: 05/04/2022

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 Model Number: 1000096
• Device Catalogue Number: 1000886
• Device Lot Number: M991649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 06/22/2022
• Supplement Dates FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2019
• 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: 43 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic